ITCH RELIF CVS- diphenhydramine hydrochloride gel

ITCH RELIF by

Drug Labeling and Warnings

ITCH RELIF by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

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.

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 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. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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

ITCH RELIF  CVS
diphenhydramine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-038
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
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
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: 69842-038-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/14/2014

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(69842-038) , label(69842-038)