Label: AWAYE- capsaicin cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 28, 2022
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- Active ingredient Purpose
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.
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredient
- Other information
- Product label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82531-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength CARYOPHYLLENE (UNII: BHW853AU9H) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) OLEIC ACID (UNII: 2UMI9U37CP) PEG-100 STEARATE (UNII: YD01N1999R) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82531-001-01 45 g in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/07/2022 Labeler - Lumiera Health Inc. (208214151)