Xpect Hydrocortisone
Anti-itch
Cintas Corp
Human Otc Drug
NDC 42961-220Xpect Hydrocortisone also known as Anti-itch is a human otc drug labeled by 'Cintas Corp'. National Drug Code (NDC) number for Xpect Hydrocortisone is 42961-220. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Xpect Hydrocortisone drug includes Hydrocortisone Acetate - .01 g/g . The currest status of Xpect Hydrocortisone drug is Active.
Drug Information:
| Drug NDC: | 42961-220 |
| 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: | Xpect Hydrocortisone |
| 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: | Anti-itch |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cintas Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | HYDROCORTISONE ACETATE - .01 g/g
|
| 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 NOT 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: | 28 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | part348 |
| 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: | Cintas Corp
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043690
|
| 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: | 3X7931PO74
|
| 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. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 42961-220-02 | 20 PACKET in 1 BOX (42961-220-02) / .9 g in 1 PACKET (42961-220-01) | 28 Mar, 2022 | N/A | No |
| 42961-220-03 | 8 PACKET in 1 BOX (42961-220-03) / .9 g in 1 PACKET (42961-220-01) | 28 Mar, 2022 | N/A | No |
| 42961-220-04 | 144 PACKET in 1 BOX (42961-220-04) / .9 g in 1 PACKET (42961-220-01) | 28 Mar, 2022 | 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 anti-itch cream
Product Elements:
Xpect hydrocortisone anti-itch hydrocortisone acetate hydrocortisone cetyl alcohol citric acid monohydrate diazolidinyl urea edetate disodium anhydrous glycerin glyceryl monostearate methylparaben mineral oil polyethylene glycol, unspecified propylene glycol propylparaben water stearic acid trolamine
Indications and Usage:
Uses temporarily relieves itching associated with minor skin irritations and rashes due to: eczema insect bites poison ivy, oak, or sumac soaps, detergents, or cosmetics jewelry
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product avoid contact with eyes
Dosage and Administration:
Directions adults and children 2 years and over apply to affected area not more than 3 to 4 times daily children under 2 years do not use, consult a physician
Package Label Principal Display Panel:
Packet label - 42961-212-01 hydrocortisone hydrocortisone acetate (equivalent to hydrocortisone 1%) net wt. 1/32 oz. (0.9g) anti-itch cream uses: for the temporary relief of itching and rashes associated with minor skin irritations due to eczema, insect bites, poison ivy/oak/sumac, soaps, cosmetics & other similar skin irritations. do not use if packet is torn or open. xpect ® first aid see box or drug facts card for complete warnings mfg. by cintas first aid & safety mason, oh 45040 packet not for individual sale (5/15) #100409 8 pack label - 42961-212-03 hydrocortisone xpect ® first aid hydrocortisone 1% hydrocortisone anti-itch cream xpect ® first aid distributed by cintas first aid & safety mason, oh 45040 product #181269 for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations. net wt per pkt 1/32 oz (0.9g) 8 packets per box 8-pck-label.jpg 20 pack label - 42961-212-02 hydro-cortisone xpect ® first aid 20 pkts per box product #100419 hydro-cortisone 1% hydrocortisone anti-itch cream xpect ® first aid hydro-cortisone 1% hydrocortisone anti-itch cream xpect ® first aid distributed by: cintas mason, oh 45040 www.cintas.com for the temporary relief of itching associated with minor skin irritations, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations. net wt per pkt 1/32 oz (0.9g) 20 pkts per box 20-pck-label.jpg 144 pack label - 42961-212-04 144 pkts per box product #100429 net wt per pkt 1/32 oz (0.9g) hydrocortisone 1% hydrocortisone anti-itch cream xpect ® first aid 144-pck-label.jpg front-label.jpg back-label.jpg
8 pack label - 42961-212-03 hydrocortisone xpect ® first aid hydrocortisone 1% hydrocortisone anti-itch cream xpect ® first aid distributed by cintas first aid & safety mason, oh 45040 product #181269 for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations. net wt per pkt 1/32 oz (0.9g) 8 packets per box 8-pck-label.jpg
20 pack label - 42961-212-02 hydro-cortisone xpect ® first aid 20 pkts per box product #100419 hydro-cortisone 1% hydrocortisone anti-itch cream xpect ® first aid hydro-cortisone 1% hydrocortisone anti-itch cream xpect ® first aid distributed by: cintas mason, oh 45040 www.cintas.com for the temporary relief of itching associated with minor skin irritations, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations. net wt per pkt 1/32 oz (0.9g) 20 pkts per box 20-pck-label.jpg
144 pack label - 42961-212-04 144 pkts per box product #100429 net wt per pkt 1/32 oz (0.9g) hydrocortisone 1% hydrocortisone anti-itch cream xpect ® first aid 144-pck-label.jpg
Further Questions:
Questions? 1-877-973-2811 monday-friday 8:00am-5:00pm