Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e1e9dc90-247b-1e07-e053-2a95a90aec9d
Route
TOPICAL
Published
Effective Date 2022-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Tea Tree Oil Ammonium Acryloyldimethyltaurate Aloe Vera Leaf Camphor (natural) Frankincense Oil Tocopherol Sunflower Oil Cetostearyl Alcohol Peg-100 Stearate Shea Butter Peppermint Oil Glucosamine Hydrochloride Pyridoxine Hydrochloride Potassium Sorbate Water Glycerin Ethylhexylglycerin Glycyrrhizinate Dipotassium Edetate Disodium Anhydrous Glyceryl Monostearate Phenoxyethanol Polyoxyl 20 Cetostearyl Ether Dimethicone Citric Acid Monohydrate Sodium Benzoate Diethylene Glycol Monoethyl Ether Choline Bitartrate .beta.-sitosterol Squalene Cetyl Esters Wax Methyl Gluceth-20 Arnica Montana Flower Dimethyl Sulfone

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-06-20

Description

Active ingredient Capsaicin 0.025%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Temporarily relieves minor pains of muscles and joints associated with arthritis,simple backache,muscle strains,bruises,sprains,cramps

Dosage and Administration

Directions:

Adults and children 18 years of age and older:

apply to affected area but no more than 3 to 4 times daily

massage onto painful area until thoroughly absorbed

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children under 18 years of age: ask a doctor

Description

Active ingredient Capsaicin 0.025%

Section 50565-1

Keep out of reach of children.

If swalowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Section 50567-7

When using this product

Read directions befbre using

use only as directed; read and follow all directions and warnings on this carton rare cases of serious bums have been reported with products of this type

do not bandage tightly or apply local heat (such as heating pads) to the area of use

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

a transient burning sensation may occur upon application but generally disappears in several days

if severe burning occurs, discontinue use immediately

do not expose the area treated With product to heat or direct sunlight

do not use at the same time as other topical analgesics,

Section 50570-1

Do not use

on wounds, damaged, or irritated skin

with a heating pad

if you are alergic to capsicum or chili peppers

Section 51727-6

Inactive ingredients:

Water (Aqua),Helanthus Annuus (Sunflower) Seed Oil, Glycerin,GlycerylStearates, Amica Montana Flower Extract,

Cetearyl Alcohol,Ceteareth-20,PEG-100 Stearate, Butyrospermum Parkii (Shea) Buffer,Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice,Dimethicone, Ethoxydiglycol, Phenoxyethanol,

Methyl Gluceth-20,Menthe Piperita Oil,Camphor,Ethylhexylglycerin,Potassium Sorbate, Glucosamine HCI,Choline Bitartrate,

Pyridoxine HCL, Glycyrrhizinate Dipotassium, Methyl sulfonyl Methane,Disodium EDTA, Boswellia carterii oil,

Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol, Citric Acid,Beta-Sitosterol, Squalene.

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredient

Capsaicin 0.025%

Section 60561-8

If pregnant or breast-feeding, ask a health professional before use


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor pains of muscles and joints associated with arthritis,simple backache,muscle strains,bruises,sprains,cramps

Dosage and Administration (34068-7)

Directions:

Adults and children 18 years of age and older:

apply to affected area but no more than 3 to 4 times daily

massage onto painful area until thoroughly absorbed

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children under 18 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swalowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Section 50567-7 (50567-7)

When using this product

Read directions befbre using

use only as directed; read and follow all directions and warnings on this carton rare cases of serious bums have been reported with products of this type

do not bandage tightly or apply local heat (such as heating pads) to the area of use

avoid contact with eyes and mucous membranes

do not apply to wounds or damaged, broken or irritated skin

a transient burning sensation may occur upon application but generally disappears in several days

if severe burning occurs, discontinue use immediately

do not expose the area treated With product to heat or direct sunlight

do not use at the same time as other topical analgesics,

Section 50570-1 (50570-1)

Do not use

on wounds, damaged, or irritated skin

with a heating pad

if you are alergic to capsicum or chili peppers

Section 51727-6 (51727-6)

Inactive ingredients:

Water (Aqua),Helanthus Annuus (Sunflower) Seed Oil, Glycerin,GlycerylStearates, Amica Montana Flower Extract,

Cetearyl Alcohol,Ceteareth-20,PEG-100 Stearate, Butyrospermum Parkii (Shea) Buffer,Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice,Dimethicone, Ethoxydiglycol, Phenoxyethanol,

Methyl Gluceth-20,Menthe Piperita Oil,Camphor,Ethylhexylglycerin,Potassium Sorbate, Glucosamine HCI,Choline Bitartrate,

Pyridoxine HCL, Glycyrrhizinate Dipotassium, Methyl sulfonyl Methane,Disodium EDTA, Boswellia carterii oil,

Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol, Citric Acid,Beta-Sitosterol, Squalene.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredient

Capsaicin 0.025%

Section 60561-8 (60561-8)

If pregnant or breast-feeding, ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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