Label: BENADRYL EXTRA STRENGTH ITCH COOLING- diphenhydramine hydrochloride and zinc acetate spray
- NDC Code(s): 69968-0270-2
- Packager: Johnson & Johnson Consumer Inc.
- 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 May 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
Benadryl®
Relief for most outdoor itches
EXTRA STRENGTH
ITCH COOLING SPRAY
Diphenhydramine HCl 2% / Topical Analgesic
Zinc acetate 0.1 % / Skin Protectant
Questions?
call 1-877-717-2824 (toll-free)
or 215-273-8755 (collect)
www.benadryl.com
Insect
BitesPoison Ivy,
Oak, SumacMosquito
BitesSunburn Minor Cuts
& ScrapesDistributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558
J&JCI 2023 Made in Canada
Pat.www.jjcipats.com
2 FL OZ (59 mL)
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INGREDIENTS AND APPEARANCE
BENADRYL EXTRA STRENGTH ITCH COOLING
diphenhydramine hydrochloride and zinc acetate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0270 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 mL ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) TROMETHAMINE (UNII: 023C2WHX2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0270-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2019 Labeler - Johnson & Johnson Consumer Inc. (118772437)