AWAYE- capsaicin cream 
Lumiera Health Inc.

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.

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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 descriptionimage description

AWAYE 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82531-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82531-001-0145 g in 1 BOTTLE; Type 0: Not a Combination Product03/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/07/2022
Labeler - Lumiera Health Inc. (208214151)

Revised: 2/2022
Document Id: d917a6c7-1b28-1c23-e053-2a95a90af39d
Set id: d9997151-adc0-4c65-b000-a7a7239b1c47
Version: 1
Effective Time: 20220228
 
Lumiera Health Inc.