ITCH ERASER GEL- diphenhydramine hcl gel

Itch Eraser Gel by

Drug Labeling and Warnings

Itch Eraser Gel by is a Otc medication manufactured, distributed, or labeled by Tender Corporation d/b/a Adventure Ready Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine HCl 2%

Purpose

Topical Analgesic

Uses

For temporrary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to posion 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, if 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 poison control center right away

Directions

Do not use more often 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: consult a doctor

Inactive ingredeints

aloe vera, citric acid, ethyl alcohol, glycerin, methocel, methylparaben, oat beat glucan, propylparaben, purified water, sodium hydroxide, tea tree oil, vitamin e

Itch Eraser Gel Box

Itch Eraser Gel Tube

INGREDIENTS AND APPEARANCE

ITCH ERASER GEL 
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-1116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE	1.14 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)	0.114 g  in 57 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.057 g  in 57 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	2.337 g  in 57 g
GLYCERIN (UNII: PDC6A3C0OX)	2.28 g  in 57 g
ALCOHOL (UNII: 3K9958V90M)	14.82 g  in 57 g
OAT (UNII: Z6J799EAJK)	0.57 g  in 57 g
WATER (UNII: 059QF0KO0R)	34.542 g  in 57 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.125 g  in 57 g
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	0.171 g  in 57 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.0741 g  in 57 g
TEA TREE OIL (UNII: VIF565UC2G)	0.285 g  in 57 g
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)	1.14 g  in 57 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-1116-1	1 in 1 BOX	01/01/2025
1	NDC: 44224-1116-0	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2025

Labeler - Tender Corporation d/b/a Adventure Ready Brands (064437304)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation d/b/a Adventure Ready Brands		064437304	manufacture(44224-1116) , label(44224-1116) , pack(44224-1116)