AFTER BITE XTRA- diphenhydramine hcl gel

After Bite Xtra by

Drug Labeling and Warnings

After Bite Xtra 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 Ingredients

Diphenhydramine HCl 2%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with minor burns minor cuts oscrapes insect bite 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

conditions 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 swollowed, get medical help or contact a 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 Ingredients

Aloe Vera, Ciric Acid, Ethyl Alcohol, Glycerin, Methocel, Methylparaben, Oat beta Glucan, Propylparaben, purified water, sodium hydroxide, tea tree oil, vitamin e

Dosage

Adults and children over 2 apply to affected are 3 to 4 times day not more

Primary Package

Secondary Packaging

INGREDIENTS AND APPEARANCE

AFTER BITE XTRA 
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-1276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	0.4 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	12.12 g  in 20 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.04 g  in 20 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.044 g  in 20 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.02 g  in 20 g
ALCOHOL (UNII: 3K9958V90M)	5.2 g  in 20 g
GLYCERIN (UNII: PDC6A3C0OX)	0.8 g  in 20 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.82 g  in 20 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.06 g  in 20 g
TEA TREE OIL (UNII: VIF565UC2G)	0.1 g  in 20 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.26 g  in 20 g
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)	0.4 g  in 20 g
OAT (UNII: Z6J799EAJK)	0.2 g  in 20 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-1276-1	1 in 1 BOX	01/01/2025
1	NDC: 44224-1276-0	1 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(44224-1276) , label(44224-1276) , pack(44224-1276)