Active Ingredient
Diphenhydramine Hydrochloride 2%
Zinc Acetate 0.1%
Itch Relief Cream
FDA Label NDC 69452-449
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 Itch Relief (NDC 69452-449). 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, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Skin Protectant
Uses
■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac
■ temporarily relieves pain and itching associated with:
■ minor cuts ■ sunburn ■ scrapes
■ minor skin irritations ■ minor burns ■ insect bites
■ rashes due to poison ivy, poison oak and poison sumac
Warnings
For external use only.
Do not use
■ with any other product containing diphenhydramine, even one taken by mouth
■ on large areas of the body
■ on broken, blistered, or oozing skin
Ask A Doctor Before Use
■ on measles ■ on chicken pox ■ on poison ivy ■ on sunburn
When Using This Product
avoid contact with the 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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ children under 2 years of age: ask a doctor
■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
■ do not use more than directed
Other Information
■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use
■ Lot No. & Exp. Date: See box or crimp of tube
Inactive Ingredients
carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60,
propylparaben, purified water, stearic acid
Other
READ AND KEEP CARTON FOR COMPLETE INFORMATION
*This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream.
Manufactured for: Bionpharma Inc., Princeton, NJ 08540
MADE IN INDIA
GUJ/DRUGS/G/25/2134
L0000814
R0424
LOT & EXP.
Tube Carton
* compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream
NDC 69452-449-37
a+ health TM
itch relief cream
diphenhydramine HCl 2 % + zinc acetate 0.1%
net wt. 1.25 oz
dye-free • phthalate-free • fragrance-free
• extra strength
• topical analgesic
• skin protectant
Image001 (Image001)
* Please review the disclaimer below.
