Capsaicin CAPSAICIN SA3, LLC FDA Approved Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains
Generic: CAPSAICIN
Mfr: SA3, LLC FDA OTC
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Substance Capsaicin
Route
TOPICAL
Applications
M017

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Capsaicin 0.025%
Inactive Ingredients
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
Strengths
0.025 %
Quantities
5 count 1 count
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Of Muscles And Joints Due To Simple Backache Arthritis Strains Sprains

Identifiers & Packaging

Container Type UNKNOWN
UNII
S07O44R1ZM
Packaging

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

Package Descriptions
  • 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

Overview

Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains

Indications & Usage

Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains

Dosage & Administration

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

Warnings & Precautions
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 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 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.
Purpose

Purpose Topical analgesic

Do Not Use

Do not • Apply to wounds or damaged skin • Bandage tightly • If you are allergic to capsicum or chili peppers

When Using

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 & Ask a Doctor

Stop use and as k 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

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.

Storage & Handling

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


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