CAPSAICIN- capsaicin cream 
SA3, LLC

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 Cream

CAPSAICIN – Capsaicin 0.025% Cream

SA3, LLC

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.

----------

Capsaicin 0.025% Cream


Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

Topical 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

• Apply to wounds or damaged skin

• Bandage tightly

• 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 if symptoms persist for more than 7 days or clear up and occur again within a few days

• Severe burning persists or blistering occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 2 years of age and older:

Apply to affected area not more than 3 to 4 times daily. Wash hands thoroughly with soap and water immediately after application.

Children under 2 years: consult a doctor

Other information

Store at room temperature 15°-30°C (59°-86°F). Protect the product from excessive heat and direct sun.

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 0.025% cream

NDC 69420-6025-5

50 grams

SA3, LLC

PRINCIPAL DISPLAY PANEL
Capsaicin 0.025% cream
NDC 69420-6025-5
50 grams

SA3, LLC

PRINCIPAL DISPLAY PANEL

Capsaicin 0.025% cream

NDC 69420-6025-1

120 grams

SA3, LLC

PRINCIPAL DISPLAY PANEL
Capsaicin 0.025% cream
NDC 69420-6025-1
120 grams

SA3, LLC

CAPSAICIN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69420-6025
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
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69420-6025-550 g in 1 TUBE; Type 0: Not a Combination Product06/11/2021
2NDC:69420-6025-1120 g in 1 TUBE; Type 0: Not a Combination Product06/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/11/2021
Labeler - SA3, LLC (079627454)

Revised: 5/2022
Document Id: e7e22437-209f-43e4-b698-2df6bd05a46b
Set id: 5617e91d-e650-4a0d-8565-b8288ea41c77
Version: 2
Effective Time: 20220517
 
SA3, LLC