DIPHENHYDRAMINE- diphenhydramine hcl, zinc acetate cream

Diphenhydramine by

Drug Labeling and Warnings

Diphenhydramine by is a Otc medication manufactured, distributed, or labeled by NexMed (USA), Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

• 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

QUESTIONS

Call 1-866-580-7391, Mon - Fri, 8:30 AM - 5:30 PM (PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE   D
diphenhydramine hcl, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40002-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40002-004-03	1 in 1 CARTON
1	NDC: 40002-004-02	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/29/2011

Labeler - NexMed (USA), Inc. (031710528)

Registrant - NexMed (USA), Inc. (031710528)