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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine HCl 2%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with

• insect bites
• minor burns
• sunburn
• minor skin irritations
• minor cuts
• rashes due to poison ivy, poison oak, and poison sumac

Warnings

For external use only

Do not use

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

Ask a doctor before use

• on chicken pox
• on measles

When using

When using this product avoid contact with eyes.

Stop use and ask a doctor if

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

• do not use more than directed
• adults and children over 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

Inactive Ingredients

Aloe Vera, Citric Acid, Ethyl Alcohol, Glycerin, Methocel, Methylparaben, Oat Beta Glucan, Propylparaben, Purified Water, Sodium Hydroxide, Tea Tree Oil, Vitamin E

Package Labeling

INGREDIENTS AND APPEARANCE

AFTER BITE XTRA 
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-0127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
TEA TREE OIL (UNII: VIF565UC2G)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
OATMEAL (UNII: 8PI54V663Y)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-0127-1	1 in 1 BOX	03/01/2018
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 44224-0127-0	20 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2018

Labeler - Tender Corporation (064437304)

Registrant - Tender Corporation (064437304)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation		064437304	manufacture(44224-0127)