CAPSAICIN CREAM- capsaicin cream

Capsaicin Cream by

Drug Labeling and Warnings

Capsaicin Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Capsaicin 0.1%

Purpose

Topical Analgesic

Warnings

For external use only: TEST FIRST ON SMALL AREA OF SKIN.

When using this product:

• Use only as directed
• Do not apply to wounds, damaged, broken or irritated skin
• Avoid contact with the eyes or mucous membranes
• A slight burning sensation may occur upon application, but generally disappears after several days
• If severe burning occurs, discontinue use
• Do not expose the treated area to heat or direct sunlight
• Do not bandage
• Do not use with heating pad
• Do not use at the same time as other topical analgesics

Stop Use and Ask Doctor

Stope Use and Ask Doctor if:

• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• Redness is present
• irritation develops
• You experience signs of skin injury such as pain, swelling or blistering.

Keep Out of the Reach of Children

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

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises

If Pregnant or Breast Feeding

Ask a doctor before use

Directions

Adults and Children over 18 years:

• Apply to affected area
• Massage into the painful area until thoroughly absorbed
• Repeat as necessary but not more than 3 to 4 times daily
• WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Children 18 years and younger:

Ask a doctor

Inactive Ingredients

Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic Acid

Other Information

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

This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.

Questions

Questions or Comments

Please call Toll Free 1-888-296-9067

Other Information

Distributed by

Trifecta Pharmaceuticals USA

101 NE Third Aveue, Suite 1500

Fort Lauderdale, FL 33301

www.trifecta-pharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAPSAICIN CREAM 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURETH-23 (UNII: N72LMW566G)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLPARABEN (UNII: 14255EXE39)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-103-02	1 in 1 BOX	05/14/2022
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/14/2022

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)