70947-010-04

70947-010-04
SPL v7
SPL
SPL Set ID 3b8c2419-7a78-2731-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2023-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (10 g) Camphor (natural) (3 g)
Inactive Ingredients
Linalool, (+/-)- Polysorbate 60 Trolamine Mineral Oil Glyceryl Stearate Se Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Amino Acids, Wheat Panthenol Alcohol Stearic Acid Cetostearyl Alcohol Cetyl Alcohol Dimethicone Glycereth-26 Propylene Glycol Diazolidinyl Urea Methylparaben Propylparaben Symphytum Officinale Whole Hydroxyproline Stearyl Alcohol Trideceth-6 Hyaluronate Sodium Sodium Pyrrolidone Carboxylate Benzyl Benzoate Polysorbate 20 Water Geraniol Coumarin Limonene, (+)-

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-01

Description

Camphor 3% Menthol 10%


Medication Information

Warnings and Precautions

•For external use only.

•Use only as directed.

•Do not bandage tightly.

•Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

Description

Camphor 3% Menthol 10%

Uses:

For the temporary relief of minor aches and pains of muscles and joints

associated with simple backache, arthritis, sprains and strains

Section 50565-1

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

Section 50567-7

Avoid contact with eyes, mucous membranes, rashes.

Do not apply to wounds or damaged skin.

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 this product, and consult a doctor.

Section 50569-3

Ask a doctor before use if you have redness over affected area

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Dimethicone, Glycereth-26, Polysorbate 60, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

External Analgesic

Section 55106-9

Camphor 3%

Menthol 10%

Directions:

Adults and children over 12 years of age

apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.

Wash hands with soap and water after use.

Children under 12 years of age; do not use unless directed by doctor.

Other Information:

Store at room temperature 15º - 30ºC (59º - 86º F)

Questions Or Comments?

Contact us +1-305-468-8720

Eternal Spirit Beauty Painless Pain Relieving Cream Sachet

Eternal Spirit Beauty Painless Pain Relieving Cream 4 Fl Oz


Structured Label Content

Uses: (USES:)

For the temporary relief of minor aches and pains of muscles and joints

associated with simple backache, arthritis, sprains and strains

Warnings and Precautions (34071-1)

•For external use only.

•Use only as directed.

•Do not bandage tightly.

•Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

Avoid contact with eyes, mucous membranes, rashes.

Do not apply to wounds or damaged skin.

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 this product, and consult a doctor.

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over affected area

Section 51727-6 (51727-6)

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Dimethicone, Glycereth-26, Polysorbate 60, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

Section 53414-9 (53414-9)

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)

Camphor 3%

Menthol 10%

Directions: (DIRECTIONS:)

Adults and children over 12 years of age

apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.

Wash hands with soap and water after use.

Children under 12 years of age; do not use unless directed by doctor.

Other Information: (OTHER INFORMATION:)

Store at room temperature 15º - 30ºC (59º - 86º F)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Contact us +1-305-468-8720

Eternal Spirit Beauty Painless Pain Relieving Cream Sachet (ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING CREAM SACHET)

Eternal Spirit Beauty Painless Pain Relieving Cream 4 Fl Oz (ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING CREAM 4 fl oz)


Advanced Ingredient Data


Raw Label Data

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