Capsaicin by SA3, LLC CAPSAICIN cream

Capsaicin by

Drug Labeling and Warnings

Capsaicin by is a Otc medication manufactured, distributed, or labeled by SA3, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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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: 69420-6025-1

120 grams

SA3, LLC

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69420-6025
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69420-6025-5	50 g in 1 TUBE; Type 0: Not a Combination Product	06/11/2021
2	NDC: 69420-6025-1	120 g in 1 TUBE; Type 0: Not a Combination Product	06/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/11/2021

Labeler - SA3, LLC (079627454)