Capsaicin by Alexso, Inc CAPSAICIN cream

Capsaicin by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CAPSAICIN – Capsaicin 0.025% 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 0.025% Cream

Drug Facts

Active ingredient

Capsaicin 0.025%

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

Capsaicin 0.025% cream

NDC: 50488-1025-1

120 grams

Capsaicin 0.025% cream

NDC: 50488-1025-5

50 grams

Capsaicin 0.025% cream

NDC: 50488-1025-2

25 grams

Alexso, Inc

PRINCIPAL DISPLAY PANEL

NDC: 50488-1025-1
Capsaicin 0.025% Cream
120 grams

PRINCIPAL DISPLAY PANEL

NDC: 50488-1025-5
Capsaicin 0.025% Cream
50 grams

PRINCIPAL DISPLAY PANEL

NDC: 50488-1025-2
Capsaicin 0.025% Cream
25 grams

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-1025
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)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-1025-1	1 in 1 CARTON	10/01/2018
1		120 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 50488-1025-5	1 in 1 CARTON	10/01/2018
2		50 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 50488-1025-2	1 in 1 CARTON	10/01/2018
3		25 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	10/01/2018

Labeler - Alexso, Inc (963338061)