Skin Pharmacy Advanced Acne Therapy Kit
Salicylic Acid, Benzoyl Peroxide
Amcol Health & Beauty Solutions, Inc. Dba
Human Otc Drug
NDC 68634-067Skin Pharmacy Advanced Acne Therapy Kit also known as Salicylic Acid, Benzoyl Peroxide is a human otc drug labeled by 'Amcol Health & Beauty Solutions, Inc. Dba'. National Drug Code (NDC) number for Skin Pharmacy Advanced Acne Therapy Kit is 68634-067. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Skin Pharmacy Advanced Acne Therapy Kit drug includes . The currest status of Skin Pharmacy Advanced Acne Therapy Kit drug is Active.
Drug Information:
| Drug NDC: | 68634-067 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Skin Pharmacy Advanced Acne Therapy Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Salicylic Acid, Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amcol Health & Beauty Solutions, Inc. Dba |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Oct, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Apr, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333D |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | AMCOL Health & Beauty Solutions, Inc. DBA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68634-067-01 | 1 KIT in 1 CARTON (68634-067-01) * 22 mL in 1 TUBE * 12 mL in 1 TUBE * 118 mL in 1 TUBE | 01 Oct, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose acne treatment
Product Elements:
Skin pharmacy advanced acne therapy kit salicylic acid, benzoyl peroxide skin pharmacy advanced acne therapy clarifying daily cleanser salicylic acid salicylic acid salicylic acid water sodium c14-16 olefin sulfonate polyethylene glycol 4000 cocamidopropyl betaine xanthan gum dmdm hydantoin edetate disodium .alpha.-tocopherol acetate, dl- hamamelis virginiana flower water butylene glycol calendula officinalis flower licorice phenoxyethanol fd&c yellow no. 5 fd&c red no. 40 lauryl methacrylate/glycol dimethacrylate crosspolymer skin pharmacy advanced acne therapy active clearing benzoyl peroxide benzoyl peroxide benzoyl peroxide water glycerin methyl methacrylate/glycol dimethacrylate crosspolymer cetyl alcohol sorbitol glyceryl dilaurate stearyl alcohol magnesium aluminum silicate sodium citrate silicon dioxide sodium lauryl sulfate citric acid monohydrate methylparaben xanthan gum propylparaben skin pharmacy advanced acne therapy spot treatment benzoyl peroxide benzoyl peroxide benzoyl peroxide water glycerin methyl methacrylate/glycol dimethacrylate crosspolymer cetyl alcohol sorbitol glyceryl dilaurate stearyl alcohol magnesium aluminum silicate sodium citrate silicon dioxide sodium lauryl sulfate citric acid monohydrate methylparaben xanthan gum propylparaben
Indications and Usage:
Use for the management of acne
Warnings:
Warnings for external use only do not use this medication if you have very sensitive skin are sensitive to salicylic acid ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. this may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor. when using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. when using this product avoid contact with eyes. if this occurs, immediately flush with water. keep out of reach of children. in case of accidental ingestion, get medical help or contact poison control center right away.
Do Not Use:
Warnings for external use only do not use this medication if you have very sensitive skin are sensitive to salicylic acid ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. this may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor. when using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. when using this product avoid contact with eyes. if this occurs, immediately flush with water. keep out of reach of children. in case of accidental ingestion, get medical help or contact poison control center right away.
When Using:
When using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. when using this product avoid contact with eyes. if this occurs, immediately flush with water.
Dosage and Administration:
Directions use morning and night. apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes. rinse thoroughly with warm water. pat dry. if bothersome dryness or peeling occurs, reduce application to once a day or every other day. if going outside use sunscreen.
Package Label Principal Display Panel:
Principal display panel - skin+pharmacy advanced acne therapy kit carton label skin+pharmacy advanced acne therapy kit dermatologist tested bonus: includes 2 gentle facial cleansing sponges exclusively at cvs/pharmacy $35 value $19.99 one month supply principal display panel - skin+pharmacy advanced acne therapy kit carton label
Principal display panel - skin+pharmacy advanced acne therapy kit label skin+pharmacy advanced acne therapy clarifying daily cleanser with polytrap ® technology maximum strength 2% salicylic acid removes excess skin oils unclogs pores oil-free formula dermatologist tested exclusively at cvs/pharmacy 4 fl oz (118 ml) principal display panel - skin+pharmacy advanced acne therapy kit label
Principal display panel - skin+pharmacy advanced acne therapy kit label skin+pharmacy advanced acne therapy active clearing lotion with microsponge ® technology 2.5% benzoyl peroxide clinically proven to kill acne-causing bacteria clinically proven to effectively reduce inflammatory lesions soothing, oil-free formula unclogs pores fragrance free dermatologist tested exclusively at cvs/pharmacy 0.75 fl oz (22 ml) principal display panel - skin+pharmacy advanced acne therapy kit label
Principal display panel - skin+pharmacy advanced acne therapy kit label skin+pharmacy advanced acne therapy spot treatment with microsponge ® technology 5% benzoyl peroxide clinically proven to effectively reduce inflammatory lesions effectively kills acne-causing bacteria helps reduce irritation fragrance free dermatologist tested exclusively at cvs/pharmacy 0.4 fl oz (12 ml) principal display panel - skin+pharmacy advanced acne therapy kit label