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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Soundbody Anti-itch Cream

Active ingredients (in each gram)

Diphenhydramine HCl 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

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

When using this product

  • avoid contact with eyes

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

cetearyl alcohol, ethylparaben, glycerin, glyceryl stearate, mineral oil, polysorbate 80, propylene glycol, stearic acid, stearyl alcohol, water

Questions or Comments?

1-800-883-0085

Package label

Anti-Itch Cream

carton

ANTI-ITCH 
diphenhydramine hcl, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0633
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
MINERAL OIL (UNII: T5L8T28FGP)  
ETHYLPARABEN (UNII: 14255EXE39)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0633-21 in 1 BOX12/13/2013
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/13/2013
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4ee88a8-bf3b-454f-e053-2a95a90ae2a1
Set id: a3b91d7b-74a3-40ec-9228-648d491571b4
Version: 7
Effective Time: 20230217
 
Kareway Product, Inc.