Active Ingredients
Diphenhydramine HCL 2.0%
Zinc Acetate 0.1%
Diphenhydramine Hcl And Zinc Acetate Aerosol, Spray
FDA Label NDC 36800-126
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Diphenhydramine Hcl And Zinc Acetate (NDC 36800-126). 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 ingredients, purpose, uses, warnings, flammable, do not use, ask a doctor before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Skin Protectant
Uses
for the temporary relief of pain and itching associated with:
- minor burns
- sunburn
- minor cuts
- scrapes
- insect bites
- minor skin irritations
- 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 puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 °F
Intentional misuseby deliberately concentrating and inhaling contents can be harmful or fatal.
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
When Using This Product
- avoid contact with eyes
Stop Use And Ask Doctor If
- condition worsens
- symptoms last 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
- 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
Other Information
store between 20° to 25° C (68° to 77°F)
Inactive Ingredients
aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine
Questions?
Call 1-888-423-0139
Principal Display Panel
TopCare health
EXTRA STRENGTH
Itch Relief Continous Spray
DIPHENHYDRAMINE HYDROCHLORIDE 2%
EXTERNAL ANALGESIC
ZINC ACETATE 0.1%
SKIN PROTECTANT
- Relieves Itching from Insect Bites, Poison Ivy, Oak & Sumac
- Soothes Sunburn & Minor Burns & Cuts
NET WT 2.7 OZ (76g)
* Please review the disclaimer below.
