Dual-shave 2 In 1
Benzoyl Peroxide
Dual-shave Llc
Human Otc Drug
NDC 71295-101Dual-shave 2 In 1 also known as Benzoyl Peroxide is a human otc drug labeled by 'Dual-shave Llc'. National Drug Code (NDC) number for Dual-shave 2 In 1 is 71295-101. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Dual-shave 2 In 1 drug includes Benzoyl Peroxide - 5 g/100g . The currest status of Dual-shave 2 In 1 drug is Active.
Drug Information:
| Drug NDC: | 71295-101 |
| 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: | Dual-shave 2 In 1 |
| 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: | Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dual-shave Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | BENZOYL PEROXIDE - 5 g/100g
|
| 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: | 06 Mar, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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: | DUAL-SHAVE LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308696
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | W9WZN9A0GM
|
| 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 |
|---|
| 71295-101-11 | 198 g in 1 TUBE (71295-101-11) | 06 Mar, 2017 | 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:
Dual-shave 2 in 1 benzoyl peroxide benzoic acid ethylhexylglycerin glycereth-2 cocoate edetate disodium eucalyptus globulus leaf zingiber officinale whole gaultheria procumbens leaf avena sativa whole allantoin goat milk benzoyl peroxide benzoyl peroxide water myristic acid sodium c14-16 olefin sulfonate cocamidopropyl betaine stearic acid carbomer copolymer type a potassium hydroxide lauric acid glycerin glycol distearate lauramine oxide sodium methyl cocoyl taurate phenoxyethanol
Indications and Usage:
Use for the treatment of acne and to prevent skin blemishes when shaving.
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
When Using:
When using this product: skin dryness and irritation is more likely to occur when used with another topical acne medication at the same time. if irritation does occur, use less acne-fighting medication. always try to avoid added unnecessary sun exposure and always use sunscreen if possible. avoid contact with eyes, lips an mouth. if contact occurs flush thoroughly with water. skin irritation is defined by symptoms such as burning, itching, peeling, swelling or redness. if by chance irritation does occur, reduce irritation by using a smaller amount or by using this product less often.
Dosage and Administration:
Directions dual-shave is unlike other shaving gels and foams! this product is best used when shaving or washing ones face in the shower, but can also be used in traditional fashions as well. it's always best to wet area with warm water to open the pores of the skin. to shave: put a large quarter-sized amount onto clean fingertips. make sure a nice layer is covering the entire area to be shaved and add more if needed. proceed to shave. for less irritation remember to always shave in the same direction that the hair-follicle is growing. once the entire area is shaved, rinse thoroughly. it's always best to rinse face with cold water to close pores. it's very common to feel a tingly sensation... this means dual-shave is working! to use as an anti-acne facial wash: put a quarter-sized amount onto clean fingertips. make sure a nice layer is covering the entire area to be cleaned and add more if needed. apply onto face in a circular motion. once entire area is covered and saturated then rinse
Read more... well with cold water to close pores. no need to ever follow through twice for shaving or washing your face. after using dual-shave, this product will leave your face feeling crisp and clean, with no strong scent left behind.
Stop Use:
Stop use and ask a doctor if: irritation becomes acute.
Package Label Principal Display Panel:
Dual-shave tube label
Further Questions:
Questions? call direct +1 (310) 461-1980 or visit www.dual-shave.com