RITE AID MAXIMUM STRENGTH ITCH RELIEF- diphenhydramine hydrochloride gel

Rite Aid by

Drug Labeling and Warnings

Rite Aid by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                               Purpose

Diphenhydramine HCL 2% ...................................................................Topical analgesic

PURPOSE

Uses

Temporarily relieves pain and itching associated with
- minor burns - insect bites - sunburn - minor skin irritations
- minor cuts - scrapes - rashes due to poison ivy, poison oak and poison sumac

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.

INDICATIONS & USAGE

Uses

Temporarily relieves pain and itching associated with
- minor burns - insect bites - sunburn - minor skin irritations
- minor cuts - scrapes - rashes due to poison ivy, poison oak and poison sumac

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

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 if the 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.

DOSAGE & ADMINISTRATION

Directions

- do not use more than directed

- Adults and children 2 years 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

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

INACTIVE INGREDIENT

Inactive Ingredients

purified water, SD alcohol 40-B, propylene glycol, diazolidinyl urea, hydroxypropyl methylcellolose, camphor, methylparaben, citric acid, sodium citrate, propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID   MAXIMUM STRENGTH ITCH RELIEF
diphenhydramine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0370-2	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	08/10/2011

Labeler - RITE AID CORPORATION (014578892)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture