Otc - Active Ingredient
Diphenhydramine HCl 2%
A Health Itch Relief Gel
FDA Label NDC 82645-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product A Health Itch Relief Gel (NDC 82645-116). 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 otc - active ingredient, otc - purpose, indications & usage, 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
Otc - Purpose
External Analgesic
Indications & Usage
Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, 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
- 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
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.
Dosage & Administration
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: do not use, consult a doctor.
Inactive Ingredient
Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.
Questions & Comments?
1-833-551-0932
* Please review the disclaimer below.
