OTC Medication Information: Capsaicin 0.1 Percent

CAPSAICIN 0.1 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.

CAPSAICIN – Capsaicin 0.1 % 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.

Capsaicin 0.1 % Cream


Drug Facts

Active ingredient

Capsaicin 0.1%

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

Whe n us ing 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 as k 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 0.1 % C ream

NDC 50488-1060-6

6 0 grams

Alexso, Inc

PRINCIPAL DISPLAY PANEL
Capsaicin 0.1% Cream
NDC 50488-1060-6
60 grams

Alexso, Inc
(click image for full-size original)
CAPSAICIN 0.1 PERCENT
capsaicin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-1060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID
TROLAMINE
CHONDROITIN SULFATE (BOVINE)
POLYACRYLAMIDE (10000 MW)
SODIUM POLYACRYLATE (2500000 MW)
WATER
ARNICA MONTANA FLOWER
INDIAN FRANKINCENSE
CETOSTEARYL ALCOHOL
ETHYLHEXYLGLYCERIN
GLUCOSAMINE SULFATE
GLYCERIN
GLYCERYL MONOSTEARATE
C13-14 ISOPARAFFIN
ISOSTEARYL PALMITATE
LAURETH-7
DIMETHYL SULFONE
PEG-100 STEARATE
PHENOXYETHANOL
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50488-1060-6 60 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 02/01/2020
Labeler — Alexso, Inc (963338061)

Revised: 02/2020 Alexso, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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