ITCH RELIEF GEL- diphenhydramine hcl gel

Itch Relief Gel by

Drug Labeling and Warnings

Itch Relief Gel by is a Otc medication manufactured, distributed, or labeled by Walgreens, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Diphenhydramine HCL 2%

Purpose

Topical Analgesic

Use

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

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 eyes

Stop use and ask a doctor if

condition worsens, 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

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.

Other information

Store at room temperature

Inactive ingredients

camphor, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

Questions?

1-800-925-4733

Directions

Apply to affected area not more thatn 3 to 4 times daily

Tube label

INGREDIENTS AND APPEARANCE

ITCH RELIEF GEL 
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2.03 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)	47.12 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	42.5 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	4 g  in 100 g
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.5 g  in 100 g
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.20 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.20 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.10 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)	.50 g  in 100 g
alcohol (UNII: 3K9958V90M)	2.00 g  in 100 g
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)	.75 g  in 100 g

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0353-04	120.06 g in 1 TUBE; Type 0: Not a Combination Product	05/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/30/2018

Labeler - Walgreens (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(0363-0353)