Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 16b47cb5-ea5f-4514-9a89-141ee4cc60f8
Route
TOPICAL
Published
Effective Date 2012-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 mg)
Inactive Ingredients
Butyl Acrylate/methacrylic Acid Copolymer (2% Methacrylic Acid) Carboxymethylcellulose Sodium Polyvinyl Alcohol Sorbitol Glycerin Titanium Dioxide Edetate Disodium Algeldrate Malic Acid Water Butylparaben Methylparaben Polyoxyl 60 Hydrogenated Castor Oil Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-11-22

Description

Active ingredient     Capsicum extract 0.04% (Containing Capsaicin 0.025%)


Medication Information

Warnings and Precautions

Warnings

For external use only



Indications and Usage

Uses  temporary relieves minor aches and pains of muscles and joints associated with

■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

Dosage and Administration

Directions

■ Adults and children 2 years of age and over:

■ strip off the polyethylene film and place adhesive pad over affected area

■ pad may be cut with scissors for small areas such as fingers

■ change pad 1 or 2 times a day

■ apply to affected area not more than 3 or 4 times daily

■ Children under 2 years of age: do not use, consult a doctor

Description

Active ingredient     Capsicum extract 0.04% (Containing Capsaicin 0.025%)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.





Section 50566-9

Stop use and ask a doctor if



■ rash, itching or excessive irritation develops ■ redness occurs ■ condition worsens



■ symptoms persist for more than 7 days ■ symptoms clear up and occur again withn a few days





Section 50567-7

When using this product



■ avoid contact with eyes or mucous membranes ■ do not cover with any additional wrap

Section 50570-1

Do not use



■ on wounds, or on damaged, or irritated skin



■ on children under 12 years with arthritis-like conditions unless directed by a doctor





Section 51727-6

Inactive ingredients

Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide



Section 51945-4











Section 55105-1

Purpose

Capsaicin    External analgesic

Section 55106-9

Active ingredient    

Capsicum extract 0.04% (Containing Capsaicin 0.025%)

Section 60561-8

Other information

■ store unused pads in the pouch  ■ reseal the pouch after opening and keep tightly closed


Structured Label Content

Indications and Usage (34067-9)

Uses  temporary relieves minor aches and pains of muscles and joints associated with

■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

Dosage and Administration (34068-7)

Directions

■ Adults and children 2 years of age and over:

■ strip off the polyethylene film and place adhesive pad over affected area

■ pad may be cut with scissors for small areas such as fingers

■ change pad 1 or 2 times a day

■ apply to affected area not more than 3 or 4 times daily

■ Children under 2 years of age: do not use, consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.





Section 50566-9 (50566-9)

Stop use and ask a doctor if



■ rash, itching or excessive irritation develops ■ redness occurs ■ condition worsens



■ symptoms persist for more than 7 days ■ symptoms clear up and occur again withn a few days





Section 50567-7 (50567-7)

When using this product



■ avoid contact with eyes or mucous membranes ■ do not cover with any additional wrap

Section 50570-1 (50570-1)

Do not use



■ on wounds, or on damaged, or irritated skin



■ on children under 12 years with arthritis-like conditions unless directed by a doctor





Section 51727-6 (51727-6)

Inactive ingredients

Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide



Section 51945-4 (51945-4)











Section 55105-1 (55105-1)

Purpose

Capsaicin    External analgesic

Section 55106-9 (55106-9)

Active ingredient    

Capsicum extract 0.04% (Containing Capsaicin 0.025%)

Section 60561-8 (60561-8)

Other information

■ store unused pads in the pouch  ■ reseal the pouch after opening and keep tightly closed


Advanced Ingredient Data


Raw Label Data

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