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Drug Facts
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558
Benadryl Extra Strength Itch Cooling Spray
FDA Label NDC 69968-0270
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Benadryl Extra Strength Itch Cooling (NDC 69968-0270). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, ask a doctor before use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Diphenhydramine HCl 2% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
Uses
- temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor skin irritations
- minor cuts
- scrapes
- rashes due to poison ivy, poison oak, and poison sumac
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
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
Ask A Doctor Before Use
- on chicken pox
- on measles
Otc - When Using
When using this product avoid contact with eyes
Stop Use And Ask A Doctor If
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - 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 2 years of age and older: spray on affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Other Information
- store at 20° to 25° C (68° to 77° F)
Inactive Ingredients
alcohol, glycerin, PVP, purified water, tromethamine
Questions?
call 1-800-524-2624 (English/Spanish)
Principal Display Panel - 59 Ml Bottle Label
EXTRA STRENGTH
Benadryl®
Topical Analgesic/Skin Protectant
ITCH COOLING SPRAY
Relief for most
outdoor itches
| Insect Bites | Poison Ivy, Oak, Sumac | Mosquito Bites | Sunburn | Minor Cuts & Scrapes |
2 FL OZ (59 mL)
Principal Display Panel (59 mL Bottle Label)
* Please review the disclaimer below.
