Reactheat Reactivating Heat Baume

Reactheat Reactivating Heat Baume
SPL v3
SPL
SPL Set ID a74f0c33-930c-4ff8-9e7a-2c7539b66272
Route
TOPICAL
Published
Effective Date 2012-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mL) Bird Pepper (0.5 mL)
Inactive Ingredients
Water Dimethyl Sulfone Clove Oil Peppermint Oil Eucalyptus Oil Aloe Vera Leaf Ascorbic Acid Tocopherol Glycine Jojoba Oil Arnica Montana Flower C13-14 Isoparaffin Laureth-7 Sodium Hydroxymethylglycinate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-20

Description

Active Ingredients                Purpose Menthol (5%)                       External Analgesic Capsicum Annum Extract (0.5)     External Analgesic


Medication Information

Warnings and Precautions

For external use only. When using this product, avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing, seeking the advice of your doctor before using this product.

Indications and Usage


Consult a doctor and discontinue use if condition worsens or persists for more than 7 days.

Dosage and Administration

Directions for use

Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area no more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Description

Active Ingredients                Purpose Menthol (5%)                       External Analgesic Capsicum Annum Extract (0.5)     External Analgesic

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, DImethyl Sulfone, Clove Bud Oil, Peppermint Oil, Eucalyptus Oil, Aloe vera, Ascorbic Acid, Tocopherol, Glycine, Wintergreen Oil, Jojoba Oil, Arnica Montana Flower Extract, Polyarylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.





Section 51945-4




Reactheat

Reactivating Heat Baume



4 fl. oz./ 118.29ml















Section 55105-1

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises and sprains.

Section 55106-9

Active Ingredients                Purpose

Menthol (5%)                       External Analgesic

Capsicum Annum Extract (0.5)     External Analgesic


Structured Label Content

Indications and Usage (34067-9)


Consult a doctor and discontinue use if condition worsens or persists for more than 7 days.

Dosage and Administration (34068-7)

Directions for use

Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area no more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Warnings and Precautions (34071-1)

For external use only. When using this product, avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing, seeking the advice of your doctor before using this product.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water, DImethyl Sulfone, Clove Bud Oil, Peppermint Oil, Eucalyptus Oil, Aloe vera, Ascorbic Acid, Tocopherol, Glycine, Wintergreen Oil, Jojoba Oil, Arnica Montana Flower Extract, Polyarylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.





Section 51945-4 (51945-4)




Reactheat

Reactivating Heat Baume



4 fl. oz./ 118.29ml















Section 55105-1 (55105-1)

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises and sprains.

Section 55106-9 (55106-9)

Active Ingredients                Purpose

Menthol (5%)                       External Analgesic

Capsicum Annum Extract (0.5)     External Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)