CAPSAICIN 0.075 PERCENT- capsaicin cream 
Alexso, 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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Capsaicin 0_075 Percent Cream

Capsaicin 0.075% Cream


Drug Facts

Active ingredient

Capsaicin 0.075%

Purpose

External analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

• simple backache

• arthritis

• strains

• sprains

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Do not use

• On wounds or damaged skin

• If you are allergic to capsicum or chili peppers

When using this product

• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

• Avoid contact with the eyes, lips, nose and mucous membranes

• Do not tightly wrap or bandage the treated area

• Do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if

• Condition worsens or does not improve after regular use

• Severe burning persists or blistering occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 18 years of age and older:

Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily.

Children under 18 years: Ask a doctor

Other information

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

PRINCIPAL DISPLAY PANEL

Capsaicin 0.075% Cream

NDC 50488-1075-6

120 grams

Alexso, Inc

Capsaicin 0.075% Cream
NDC 50488-1075-6
120 grams

Alexso, Inc

CAPSAICIN 0.075 PERCENT 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-1075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.075 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-1075-6120 g in 1 BOTTLE; Type 0: Not a Combination Product12/08/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/08/2021
Labeler - Alexso, Inc (963338061)

Revised: 12/2021
Document Id: a385c645-bfa1-427c-bb81-31ca56326cfa
Set id: 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd
Version: 1
Effective Time: 20211208
 
Alexso, Inc