Otc - Active Ingredient
Pramoxine Hydrochloride 1%
Pramoxine Itch Relief Cream
FDA Label NDC 51316-141
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Pramoxine Itch Relief (NDC 51316-141). 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, otc - when using, otc - ask doctor, otc - do not use, otc - 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
Otc - Purpose
External Analgesic
Indications & Usage
For the temporary relief of itching associated with minor skin irritations
Warnings
For external use only
Otc - When Using
When using this product, do not get into eyes
Otc - Ask Doctor
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
Otc - Do Not Use
Do not use on
- deep or puncture wounds
- animal bites
- serious burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)
Dosage & Administration
Directions:
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 : consult a doctor
Inactive Ingredient
Aloe Vera, Behenic Acid, Cetearyl Alcohol, Cetyl Alcohol, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate, Petrolatum, Phenoxyethanol, Phystosphingosine, Polyglyceryl- 6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Shea butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Stearic Acid, Triethanolamine, Triethyl Citrate, Water, Xanthan Gum
* Please review the disclaimer below.
