After Bite Outdoor by Adventure Ready Brands After Bite Outdoor

Drug Details [pdf]

AFTER BITE OUTDOOR- diphenhydramine hcl gel
Adventure Ready Brands

----------

After Bite Outdoor

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

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

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

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 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

Box

AFTER BITE OUTDOOR
diphenhydramine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90107-1560
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 90107-1560-1	1 in 1 BOX	09/01/2020
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 90107-1560-0	20 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	09/01/2020	12/27/2024

Labeler - Adventure Ready Brands (064437304)

Registrant - Adventure Ready Brands (064437304)

Name	Address	ID/FEI	Business Operations
Establishment
Adventure Ready Brands		064437304	manufacture(90107-1560)

Revised: 12/2024

Document Id: 2a4835ef-9449-16d8-e063-6394a90ab00a

Set id: af99970d-59f9-109b-e053-2a95a90a4dd9

Version: 2

Effective Time: 20241227