Quality Choice Extra Strength Anti Itch
FDA Label NDC 63868-947

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Extra Strength Anti Itch (NDC 63868-947). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                                                               Purpose

Diphenhydramine hydrochloride USP, 2%.............................................Antihistamine

Zinc acetate, 0.1%.............................................................................Skin protectant

Otc - Purpose

Uses

  • for the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on chicken pox, measles, sunburn, oozing skin, broken blisters or on extensive areas of the skin more than directed
  • any other drug containing diphenhydramine while using this product

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if condition worsens, or if symptoms persists for more than 7 days, or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Indications & Usage

Directions

  • adults and children 12 years of age and older,apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
  • children under 12 years of age, consult a doctor

Storage And Handling

Other information

  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

glycerin, sodium chloride, petrolatum, cetyl alcohol, dimethicone, isopropyl palmitate, distearyldimodium chloride (1-Octadecanaminium, N, N-Dimmethyl-N-Octadecyl-Chloride), methylparaben, propylparaben, purified water, hydroxyethyl cellulose

Dosage & Administration

DISTRIBUTED BY QUALITY CHOICE

NOVI, MI 48376-0995

MADE IN KOREA

QC 94731

www.chaindrug.com

Package Label.Principal Display Panel

Image Of Carton Label (Qcantiitch)

Image Of Carton Label (Qcantiitch)

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