EXTRA STRENGTH FIRST AID ANTI-ITCH RITE AID PHARMACY- diphenhydramine hcl 2% gel

Extra strength first aid anti-itch by

Drug Labeling and Warnings

Extra strength first aid anti-itch by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                              Purpose
Diphenhydramine HCI 2%................Topical analgesic

INDICATIONS & USAGE

Uses Temporarily relieves pain due to: minor burns insect bites sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak & poison sumac

PURPOSE

WARNINGS

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
When using this product avoid contact with the eyes
Stop use and ask doctor if condition gets worse symptoms last more than 7 days symptoms clear up and occur again in a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 children under 2 years of age: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients

Camphor, Citric Acid, Diazolidinyl
Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben,
Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium
Citrate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH FIRST AID ANTI-ITCH  RITE AID PHARMACY
diphenhydramine hcl 2% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-7797
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 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
Sodium Citrate (UNII: 1Q73Q2JULR)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-7797-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2013

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-7797) , label(11822-7797)