Tei-fu Recovery Massage Lotion

Tei-fu Recovery Massage Lotion
SPL v5
SPL
SPL Set ID 7bc2989f-dfb6-e8af-e053-2991aa0a0bf2
Route
TOPICAL
Published
Effective Date 2018-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g) Salicylic Acid (10 g)
Inactive Ingredients
Cetostearyl Alcohol Eucalyptus Oil Stearyl Phosphate Peppermint Hydroxyacetophenone Arnica Montana Flower Carboxymethylcellulose Sodium, Unspecified Form Guar Gum Xanthan Gum Camphor Oil Clove Leaf Oil Benzyl Alcohol Phytate Sodium C13-15 Alkane Glycerin Almond Oil Ginger Oil Stearyl Alcohol Pentylene Glycol Medium-chain Triglycerides Microcrystalline Cellulose Water Glyceryl Monostearate Docosanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-28

Description

Active ingredient Purpose Menthol (5.0%) Topical Analgesic Methyl Salicylicate (10%) Topical Analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only.

Avoid contact with eyes

Do not bandage tightly

Indications and Usage

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

Dosage and Administration

Directions

Adults and children 2 year of age and older apply to affected area not more than 3 to 4 times per day

Children under 2yrs of age consult a physician.

Description

Active ingredient Purpose Menthol (5.0%) Topical Analgesic Methyl Salicylicate (10%) Topical Analgesic

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients: Water, Cinnamomium Camphora (Camphor) Bark Oil, Stearyl Alcohol, C13-15 Alkane, Glycerin, Caprylic/capric Triglyceride, Pentylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Eucalyptus Globulus Leaf Oil, Prunus Amygdalus Dulcis( sweet almond) Oil, Microcrystalline Cellulose, Mentha Piperita (peppermint) Oil, Behenyl Alcohol, Stearyl Phosphate, Eugenia Caryophyllus (Clove) Leaf Oil, Hydroxyacetophenone, Zingiber Officinale (ginger) Root Oil, Arnica Montana Flower Extract, Benzyl Alcohol, Cellulose Gum, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Sodium Phytate.

Section 51945-4

Tei-Fu

Recovery Massage Lotion

Penetrating Muscle and Joint Relief

4fl. oz. ( 118 mL)

Section 55105-1

Uses

Provides warming, penetrating pain relief for sore muscles and joints

May also provide temporary relief of minor aches and pains associated with backache, strains and bruises

Section 55106-9

Active ingredient Purpose

Menthol (5.0%) Topical Analgesic

Methyl Salicylicate (10%) Topical Analgesic


Structured Label Content

Indications and Usage (34067-9)

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

Dosage and Administration (34068-7)

Directions

Adults and children 2 year of age and older apply to affected area not more than 3 to 4 times per day

Children under 2yrs of age consult a physician.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid contact with eyes

Do not bandage tightly

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients: Water, Cinnamomium Camphora (Camphor) Bark Oil, Stearyl Alcohol, C13-15 Alkane, Glycerin, Caprylic/capric Triglyceride, Pentylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Eucalyptus Globulus Leaf Oil, Prunus Amygdalus Dulcis( sweet almond) Oil, Microcrystalline Cellulose, Mentha Piperita (peppermint) Oil, Behenyl Alcohol, Stearyl Phosphate, Eugenia Caryophyllus (Clove) Leaf Oil, Hydroxyacetophenone, Zingiber Officinale (ginger) Root Oil, Arnica Montana Flower Extract, Benzyl Alcohol, Cellulose Gum, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum, Sodium Phytate.

Section 51945-4 (51945-4)

Tei-Fu

Recovery Massage Lotion

Penetrating Muscle and Joint Relief

4fl. oz. ( 118 mL)

Section 55105-1 (55105-1)

Uses

Provides warming, penetrating pain relief for sore muscles and joints

May also provide temporary relief of minor aches and pains associated with backache, strains and bruises

Section 55106-9 (55106-9)

Active ingredient Purpose

Menthol (5.0%) Topical Analgesic

Methyl Salicylicate (10%) Topical Analgesic


Advanced Ingredient Data


Raw Label Data

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