Otc - Purpose
Topical analgesic
Westlake Outdoor Pain And Itch Relieving Cream
FDA Label NDC 82895-718
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Westlake Hb Pharma for the product Westlake Outdoor Pain And Itch Relieving (NDC 82895-718). 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 - purpose, otc - active ingredient, otc - ask doctor, otc - do not use, otc - keep out of reach of children, otc - questions, warnings, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine HCl 4%
Otc - Ask Doctor
- Condition gets worse
- symptoms last for more than 7 days
- symptoms clear up and occur again within a few days
Otc - Do Not Use
- in large quantities, particularly over raw surface or blistered areas
Otc - Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Otc - Questions
817-721-6844
Warnings
For external use onlyy
Instructions For Use
- adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
- children under 2 years: ask a doctor
Storage And Handling
store between 20°C and 25°C (68°F and 77°F)
Otc - When Using
do not get into eyes
Indications & Usage
- temporarily relieves pain and itching due to:
- minor burns
- sun burns
- minor cuts
- scrapes
- insect bite
- minor skin irritations
Dosage & Administration
apply to affected area not more than 3 to 4 times daily
Inactive Ingredient
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aleo vera) leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-30 phosphate, dicetyl phoshpate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monosterate, methylparaben, purified water, SD alcohol 40, steareth-21
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