Itch Relief Cream EXTRA STRENGTH- diphenhydramine hydrochloride and zinc acetate

Itch Relief by

Drug Labeling and Warnings

Itch Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ITCH RELIEF EXTRA STRENGTH- diphenhydramine hydrochloride and zinc acetate cream 
CVS Pharmacy

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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Itch Relief 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

CVS Health™ 

Compare to the active ingredients in Benadryl®
Extra Strength Itch Stopping Cream*
NDC: 59779-789-56 

EXTRA STRENGTH
Itch Relief Cream
Diphenhydramine HYDROCHLORIDE USP 2%
Zinc Acetate USP 0.1% 

Topical analgesic / Skin protectant 

Temporary relief of itch and pain due to:
Insect bites
Minor skin irritations
Rashes from poison ivy, poison oak or poison sumac  

NET WT 1 OZ (28g)

Itch Relief Cream
ITCH RELIEF  EXTRA STRENGTH
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-789
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59779-789-561 in 1 CARTON05/06/201608/31/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/06/201608/31/2019
Labeler - CVS Pharmacy (062312574)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 7/2019
Document Id: bea9098f-a31a-40b5-aab9-502e3a62701d
Set id: b2b06198-4188-4c12-a752-2f3fd868e3e1
Version: 4
Effective Time: 20190716
 
CVS Pharmacy