Label: AFTER BITE XTRA- diphenhydramine hcl gel
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Contains inactivated NDC Code(s)
NDC Code(s): 90107-1270-0, 90107-1270-1 - Packager: Adventure Ready Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 1, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use
- When using
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Package Labeling
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INGREDIENTS AND APPEARANCE
AFTER BITE XTRA
diphenhydramine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90107-1270 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:90107-1270-1 1 in 1 BOX 09/01/2020 1 20 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:90107-1270-0 20 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2020 Labeler - Adventure Ready Brands (064437304) Registrant - Adventure Ready Brands (064437304) Establishment Name Address ID/FEI Business Operations Adventure Ready Brands 064437304 manufacture(90107-1270)