ANTI-ITCH CREAM EXTRA STRENGTH- diphenhydramine hydrochloride and zinc acetate

Drug Labeling and Warnings

Drug Details [pdf]

ANTI-ITCH EXTRA STRENGTH- diphenhydramine hydrochloride and zinc acetate cream 
Actavis Pharma, 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.

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ANTI-ITCH CREAM EXTRA STRENGTH- diphenhydramine hydrochloride and zinc acetate

Drug Facts

Active ingredients

Diphenhydramine hydrochloride, USP 2%
Zinc acetate, USP 0.1%

Purposes

Topical analgesic
Skin protectant

Uses

For the temporary relief of pain and itching associated with
minor burns   sunburn   minor cuts   scrapes   insect bites   minor skin irritations
rashes due to poison ivy, oak and sumac
dries the oozing and weeping of poison: ivy  oak  sumac

Warnings

For external use only

Do not use

on large areas of the body   with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

on chicken pox   on measles

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition gets worse
symptoms persist for more than 7 days or clear up and occur again within a few days

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

Directions

do not use more often 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: ask a doctor

Other information

Store between 59°-86°F (15°-30°C).

Inactive ingredients

cetyl alcohol, methylparaben, polysorbate 60, propylene glycol, purified water, sorbitan monostearate

Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Principal Display Panel

Actavis

NDC 0472-0525-56

Compare to the active ingredients in Benadryl®
Extra Strength Itch Stopping Cream*

Extra Strength
Anti-Itch Cream
(Diphenhydramine Hydrochloride, USP 2%/ Zinc Acetate, USP 0.1%) 
Topical Analgesic/Skin Protectant 

Relieves Itching from Insect Bites & Skin Irritation

Net wt. 1 oz (28g)

Temporary Relief of Itch and Pain due to:
Insect Bites Minor Skin Irritations
Rashes from Poison Ivy, Poison Oak or Poison Sumac  

Ant-Itch Cream

ANTI-ITCH  EXTRA STRENGTH
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0472-0525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0472-0525-56	1 in 1 CARTON	04/19/2017	08/31/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	04/19/2017	08/31/2019

Labeler - Actavis Pharma, Inc. (119723554)

Revised: 4/2017

Document Id: eabe773c-7fac-4a71-9eea-f1f3b7d6a12f

34390-5

Set id: 5f535a25-f578-4617-8ede-684a1a7c3788

Version: 9

Effective Time: 20170420