ANTI ITCH- diphenhydramine hcl, zinc acetate cream 
Kareway Product, 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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Pure-Aid Anti-Itch Cream

Active ingredients (in each gram)

Diphenhydramine HCl 2%

Zinc acetate 0.1%

Purposes

Topical analgesic

Skin protectant

Uses

Warnings

For external use only

Do not use

  • on chicken pox or measles
  • with any other product containing diphenhydramine, even one taken by mouth
  • on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin

Stop use and ask a doctor if

  • condition worsens or does 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 reach of children

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

Directions

Other information

Inactive ingredients

Cetyl alcohol, Glycerin, Glyceryl monostearate, levelling agent0, liquid paraffin, methylparaben, octadecyl alcohol, propyl 4-hydroxybenzoate, propylene glycol, purified water, stearic acid, vaseline

Package label

Anti-Itch Cream

carton

ANTI ITCH 
diphenhydramine hcl, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0054-21 in 1 BOX08/11/2011
157 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67510-0054-11 in 1 BOX08/11/2011
228 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 finalpart34808/11/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 8/2023
Document Id: 02fd9f53-768c-ff0b-e063-6294a90a4d13
Set id: b6f8c7a3-9624-469a-b184-3f52c8908c31
Version: 5
Effective Time: 20230815
 
Kareway Product, Inc.