ANTI ITCH TOPICAL ANALGESIC- diphenhydramine hydrochloride, zinc acetate cream 
Chain Drug Marketing Associations 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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Quality Choice Extra Strength Itch Stopping Cream 1 oz. 94731 TG/CMI 2019

Active Ingredients Purpose

Diphenhydramine HCI 2%........................................................Topical analgesic

Zinc acetate, 0.1%.................................................................... Skin protectant

Uses

Warnings

For external use only

Do not use

Ask a doctor before use

When using this product avoid contact with the eyes

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

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, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

DISTRIBUTED BY:

C.D.M.A. INC.

43157 W. NINE MILE

NOVA, MI 48376-0995

Made in Korea

image description

ANTI ITCH TOPICAL ANALGESIC 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-218
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-218-011 in 1 BOX10/12/2016
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 finalpart34802/20/2014
Labeler - Chain Drug Marketing Associations Inc (011920774)

Revised: 12/2019
Document Id: 9a14c831-7437-84b0-e053-2995a90af7ba
Set id: 85ebd147-9684-4126-a4e6-d0f1046c3ac1
Version: 5
Effective Time: 20191219
 
Chain Drug Marketing Associations Inc