Diphenhydramine D

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g, ZINC ACETATE .1g in 100g
Labeler: NexMed (USA), Inc.
NDC Code: 40002-004

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.

Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical Analgesic

Skin protectant

Uses
  • For the temporary relief of itching and pain associated with:
  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

For external use only.

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 ifcondition 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
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • do not use more than directed
  • adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
  • children under 2 years of age, consult a doctor

Other information
  • Store between 20o and 25oC (68o to 77oF)
  • Lot no. and Exp. Date: see box or see crimp of tube
  • Keep box for complete instructions and labeling

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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DIPHENHYDRAMINE   D
diphenhydramine hcl, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (Diphenhydramine) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
ZINC ACETATE (ZINC) ZINC ACETATE .1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL  
DIAZOLIDINYL UREA 
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride  
METHYLPARABEN 
PEG-2 STEARATE 
PEG-20 STEARATE  
PROPYLENE GLYCOL  
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:40002-004-031 TUBE (TUBE) 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: 08/2011
 
NexMed (USA), Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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