AFTER BITE XTRA- diphenhydramine hcl gel 
Adventure Ready Brands

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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After Bite Xtra

Active Ingredient

Diphenhydramine HCl 2%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching associated with

Warnings

For external use only

Do not use

Do not use

Ask a doctor before use

Ask a doctor before use

When using

When using this product avoid contact with eyes.

Stop use and ask a doctor if

Stop use and ask a doctor if

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

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 XTRA 
diphenhydramine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-1270
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90107-1270-11 in 1 BOX09/01/2020
120 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:90107-1270-020 g in 1 TUBE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2020
Labeler - Adventure Ready Brands (064437304)
Registrant - Adventure Ready Brands (064437304)
Establishment
NameAddressID/FEIBusiness Operations
Adventure Ready Brands064437304manufacture(90107-1270)

Revised: 9/2020
Document Id: af965c5c-072b-569f-e053-2995a90a017e
Set id: af965c5c-072a-569f-e053-2995a90a017e
Version: 1
Effective Time: 20200901
 
Adventure Ready Brands