ANTI-ITCH- diphenhydramine hydrochloride gel 
Navarro Discount Pharmacies,LLC

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 (in each gram)

Diphenhydramine HCl 2%

Purposes

Topical analgesic

Skin protectant

Uses

Warnings

For external use only

Do not use

  • on chicken pox or measles
  • with any other product containing diphenhydramine, even one taken by mouth
  • on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin

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

Other information

Inactive ingredients

camphor, citric acid, ethanol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Package label

Anti-Itch Gelimage of bottle label

ANTI-ITCH 
diphenhydramine hcl gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59970-076
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59970-076-01 113 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 01/18/2013
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 1/2013
Document Id: 1ba70839-f441-46ed-90e6-007a5d1606d3
Set id: dd87c157-353f-4601-adc2-3913f21544a7
Version: 1
Effective Time: 20130118
 
Navarro Discount Pharmacies,LLC