DIPHENHYDRAMINE  D- diphenhydramine hcl, zinc acetate cream 
NexMed (USA), 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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Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical Analgesic

Skin protectant

Uses

Warnings

For external use only.

Ask a doctor before use

When using this product

Stop use and ask a doctor if

condition worsens or does not improve within 7 days, or symptoms persist for more than 7 days or clear up and occur again within a few days.


Do not 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, diazolidinyl urea, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

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Image of Carton and Label
DIPHENHYDRAMINE   D
diphenhydramine hcl, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE .1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-2 STEARATE (UNII: 94YQ11Y95F)  
PEG-20 STEARATE (UNII: NBX892EA57)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40002-004-031 in 1 CARTON
1NDC:40002-004-0228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/29/2011
Labeler - NexMed (USA), Inc. (031710528)
Registrant - NexMed (USA), Inc. (031710528)

Revised: 8/2011
Document Id: 3846ecd5-9298-40e6-84d4-e1ef8815b86e
Set id: 602c2a3a-557c-452d-a7ed-4e0e9c3b742f
Version: 1
Effective Time: 20110829
 
NexMed (USA), Inc.