70947-130-02

70947-130-02
SPL v2
SPL
SPL Set ID 0816cc8f-8d0b-de27-e063-6294a90a8a9d
Route
TOPICAL
Published
Effective Date 2023-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (10 g) Camphor (synthetic) (3 g)
Inactive Ingredients
Sodium Cocoyl Wheat Amino Acids Water Cetyl Alcohol Glycereth-26 Methylparaben Tributyl Citrate Buteth-3 Panthenol Diazolidinyl Urea Cannabidiol Hyaluronate Sodium Dimethicone 1000 Glycerin Hydroxyproline Symphytum Officinale Whole Trideceth-6 Sodium Benzotriazolyl Butylphenol Sulfonate Cetostearyl Alcohol Glyceryl Stearate Se Alcohol 95% Acrylamide Mineral Oil .alpha.-tocopherol Acetate, D- Caprylic/capric/lauric Triglyceride Polysorbate 20 Propylparaben Stearic Acid

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-05-22 Until 2027-03-10

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

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

Section 50567-7

Avoid contact with eyes

Do not apply to wounds or damaged skin.

If confition 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 51727-6

Water (Aqua), Ethyl Alcohol, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Tocopheryl Acetate, Glycereth-26, Caprylic/Capric Triglyceride, Polysorbate 60, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Propylene Glycol, Stearyl Alcohol, Polysorbate 20, Diazolidinyl Urea, Triethanolamine, Cannabidiol, Methylparaben, Propylparaben, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue No.1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 53414-9

If pregnant or breast-feeding ask a proffesional 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 affected area and rub gently not more than 3 to 4 times a day.

*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 15° - 30°C (59° - 86°F)

Questions Or Comments?

Contact us +1-305-468-8790

Ask A Doctor Before Use If You Have

Redness over affected area

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Eternal Spirit Beauty Painless With Cbd 3000 Sachet


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)

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

Section 50567-7 (50567-7)

Avoid contact with eyes

Do not apply to wounds or damaged skin.

If confition 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 51727-6 (51727-6)

Water (Aqua), Ethyl Alcohol, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Tocopheryl Acetate, Glycereth-26, Caprylic/Capric Triglyceride, Polysorbate 60, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Propylene Glycol, Stearyl Alcohol, Polysorbate 20, Diazolidinyl Urea, Triethanolamine, Cannabidiol, Methylparaben, Propylparaben, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue No.1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 53414-9 (53414-9)

If pregnant or breast-feeding ask a proffesional 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 affected area and rub gently not more than 3 to 4 times a day.

*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 15° - 30°C (59° - 86°F)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Contact us +1-305-468-8790

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

Redness over affected area

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Eternal Spirit Beauty Painless With Cbd 3000 Sachet (ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000 SACHET)


Advanced Ingredient Data


Raw Label Data

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