Anti-Itch Cream: Package Insert and Label Information

ANTI-ITCH CREAM- diphenhydramine hydrochloride and zinc acetate cream
Chain Drug Marketing Association Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin Protectant

For the temporary relief from pain and itching associated with

  • insect bites
  • minor burns
  • minor skin irritation
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries the weeping and oozing of poison ivy, oak and sumac

Warnings

For External Use Only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use on chicken pox or measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • Conditions worsen or do not improve within 7 days
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

Stop use and ask a doctor

  • Conditions worsen or do not improve within 7 days
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Do not use more than directed
  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: consult a doctor

Other information

  • Store at controlled room temperature 20º-25ºC (68º-77ºF)
  • Close cap tightly after use

Questions? Call 1-800-935-2362

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Distributed By

Distributed by CDMA Inc.

43157 W 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company owner of the registered trademark Benadryl.

Packaging

QC anti-itch-extra-strength-1oz
(click image for full-size original)

ANTI-ITCH CREAM
diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-683
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 g
ZINC ACETATE (ZINC CATION) ZINC ACETATE 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
LAURETH-23
WATER
PETROLATUM
MINERAL OIL
METHYLPARABEN
PROPYLENE GLYCOL
STEARIC ACID
GLYCERYL MONOSTEARATE
PROPYLPARABEN
ALOE VERA LEAF
CETYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-683-01 1 TUBE in 1 BOX contains a TUBE
1 28.3 g in 1 TUBE This package is contained within the BOX (63868-683-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/14/2020
Labeler — Chain Drug Marketing Association Inc. (011920774)
Registrant — Trifecta Pharmaceuticals USA LLC. (079424163)

Revised: 02/2021 Chain Drug Marketing Association Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.