Drug Facts: Active Ingredients
Diphenhydramine HCl 2%
Itch Relief Gel
FDA Label NDC 13709-351
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Itch Relief (NDC 13709-351). 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 drug facts: active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
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
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
Keep Out Of Reach Of Children If
swallowed, get medical help or contact a Poison Control Center right away, 1-800-222-1222
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
- Camphor
- diazolidinyl urea
- glycerin
- hydroxyethyl cellulose
- methylparaben
- propylene glycol
- propylparaben
- purified water
- SD alcohol 40-B
- sodium citrate
Tamper Evident
Do not use if seal on tube is punctured or missing
Questions?
1(877) 477-8633
Principal Display Panel
Itch Relief (Itchrelief)
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