Active Ingredient Purpose
Capsaicin 0.025% Topical analgesic
Awaye
FDA Label NDC 82531-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lumiera Health Inc. for the product Awaye (NDC 82531-001). 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 active ingredient purpose, uses, warning, direction, inactive ingredient, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves aches and pains of muscles and joints associated with: simple backache – lumbago – strains – sprains - arthritis
Warning
For external use only
Flammable: Keep away from fire or flame and heated surfaces.
Do not use – if you are allergic to any ingredient in this product - on open wounds, damaged, broken or irritated skin - with external heat, such as an electric heating pad or a TENS device.
When using this product – Use only as directed - Avoid contact with the eyes or mucus membranes - Do not tightly bandage - Do not inhale.
Stop use and ask a doctor if – condition worsens – headache, rash, itching, erythema, redness, burning discomfort or excessive irritation of the skin develops - symptoms persist for more than 7 days – symptoms clear up and occur again within a few days.
If pregnant or breastfeeding, ask a healthcare professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Direction
Apply 2 pumps to affected area no more than 3-4 times a day - Rub in well until absorbed by the skin - wash hands thoroughly after use with cold water - May take up to 2 weeks for a greater effect.
Inactive Ingredient
B-Caryophyllene, Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Oleic Acid, PEG100 Stearate, Polyacrylamide, Polysorbate 80, Potassium Sorbate, Purified Water, Xantham Gum.
Other Information
Store in a cool dry place away from direct sunlight – Store with cap closed tightly – Do not use if seal is broken.
Product Label
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