Active Ingredient
Diphenhydramine HCl 2%
A Health Itch Relief Gel
FDA Label NDC 69452-496
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma, Inc. for the product A Health Itch Relief Gel (NDC 69452-496). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, when using this product, 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
Purpose
External analgesic
Uses
Temporarily relieves pain due to: • minor burns • insect bites
• sunburn • minor skin irritation • minor cuts • scrapes • rashes
due to poison ivy, poison oak & 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 • measles
When Using This Product
• avoid contact with eyes
Stop Use And Ask A Doctor If
• condition gets worse • symptoms last for more than 7 days • symptoms clear up and occur again in a few days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• do not use more often 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.
Inactive Ingredients
Camphor, Citric Acid, Diazolidnyl Urea,
Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene
Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.
Questions And Comments?
call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
DISTRIBUTED BY: Bionpharma Inc., Princeton, NJ 08540
L0000940 R0125
†This product is not manufactured or distributed by the owner of the registered trademark Benadryl†®
4 Fl Oz (118 Ml) Tube
† Compare to the active ingredient
in Benadryl ® Gel
a+ health TM
extra strength
itch
relief
gel
diphenhydramine HCl 2%
topical analgesic
cooling itch relief
for insect bites
& poison ivy/oak/
sumac rashes
4 fl oz (118 mL)
DO NOT USE IF FOIL UNDER CAP IS BROKEN OR MISSING
Tube-label (Tube Label)
* Please review the disclaimer below.
