Otc - Active Ingredient
Pramoxine Hydrochloride 1%
Cvs Itch Relief Moisturizing Lotion
FDA Label NDC 51316-144
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 Health for the product Cvs Itch Relief Moisturizing (NDC 51316-144). 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 - stop use, 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
Use for the temporary relief of itching associated with minor skin irritations
Warnings
For external use only
Otc - When Using
do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Otc - Do Not Use
Do not use on
- animal bites
- severe puncture wounds or burns
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Immediately (1-800-222-1222)
Dosage & Administration
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
Allantion, Aloe Vera, Arginine PCA, Behenic Acid, Ceramide AP, Ceramide EOP, Ceramide NP, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, Niacinamide, PEG 100 Stearate, Isopropyl Palmitate, Niacinamide, PEG 100 Stearate, Phenoxyethanol, Phytosphingosine, Polyglyceryl-2- Diisostearate, polyglyceryl-6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Purified water, Shea Butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Sodium PCA, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Triethyl Citrate, Xanthan Gum, Zinc Citrate.
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