1. Home
  2. Labeler Index
  3. Lumiera Health Inc.
  4. 82531-001
  5. Label Information: Awaye

FDA Label for Awaye

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT                                   PURPOSE
    2. USES
    3. WARNING
    4. DIRECTION
    5. INACTIVE INGREDIENT
    6. OTHER INFORMATION
    7. PRODUCT LABEL

Awaye Product Label

The following document was submitted to the FDA by the labeler of this product Lumiera Health Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient                                   Purpose



Capsaicin 0.025%                                 Topical analgesic


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



image description - Image 1

image description - Image 1


* Please review the disclaimer below.