DUANE READE ANTI-ITCH- diphenhydramine hydrochloride cream

Duane Reade by

Drug Labeling and Warnings

Duane Reade by is a Otc medication manufactured, distributed, or labeled by Duane Reade, Creations Garden Natural Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine hydrochloride 2%........Topical analgesic
Zinc acetate 0.1%.......Skin protectant

Uses

• temporarily relieves pain and itching 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

Do not use

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

Ask a doctor before use

• on chicken pox  
  
• on measles

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

• do not use more often than directed
• adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• To open: unscrew cap, use pointed end of cap to puncture seal.
  
• store at room temperature
  
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

purified water aqua/eau; cetyl alcohol; glyceryl stearate; peg-100 stearate; propylene glycol; sodium polyacrylate and ethylhexyl stearate and trideceth-6; methylparaben; propylparaben

Questions

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

DUANE READE  ANTI-ITCH
diphenhydramine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (PHENOL - UNII:339NCG44TV)	DIPHENHYDRAMINE HYDROCHLORIDE	.568 g  in 28.4 g
ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC - UNII:J41CSQ7QDS)	ZINC ACETATE ANHYDROUS	.284 g  in 28.4 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-035-18	1 in 1 BOX
1		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	02/01/2011

Labeler - Duane Reade (961956229)

Registrant - Creations Garden Natural Products Inc. (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products Inc.		961956229	manufacture