Label: DUANE READE ANTI-ITCH- diphenhydramine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24488-035-18 - Packager: Duane Reade
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 1, 2011
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- Active Ingredient
- Uses
- Warnings
- Do not use
- Ask a doctor before use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DUANE READE ANTI-ITCH
diphenhydramine hydrochloride creamProduct 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