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JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558
Benadryl Extra Strength Itch Stopping Gel
FDA Label NDC 69968-0242
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 Stopping (NDC 69968-0242). 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, active ingredient, purpose, use, warnings, do not use, ask a doctor before use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Diphenhydramine HCl 2%
Purpose
Topical analgesic
Use
- temporarily relieves pain and itching associated with:
- insect bites
- minor burns
- sunburn
- minor cuts
- scrapes
- minor skin irritations
- 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
Otc - When Using
When using this product avoid contact with eyes
Stop Use And Ask A Doctor If
- condition worsens
- 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: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Other Information
Store at Room Temperature
Inactive Ingredients
SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
Questions?
call toll-free 800-524-2624 or 215-273-8755 (collect)
Principal Display Panel - 103 Ml Tube Label
EXTRA STRENGTH
Benadryl ®
ITCH STOPPING
GEL
Diphenhydramine
Hydrochloride
Topical Analgesic
FOR SKIN USE ONLY
Cooling relief for
most outdoor itches
| Insect
Bites | Poison Ivy,
Oak, Sumac | Mosquito
Bites | Sunburn | Minor Cuts
& Scrapes |
3.5 FL OZ (103 mL)
Principal Display Panel (103 mL Tube Label)
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