72524-640-04

72524-640-04
SPL v8
SPL
SPL Set ID b97f6b71-7de7-3217-e053-2a95a90aa426
Route
TOPICAL
Published
Effective Date 2024-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, (+)- (4 g) Camphor (natural) (6 g)
Inactive Ingredients
Trolamine Mineral Oil Glucosamine Sulfate Water Glycerin Arnica Montana Whole Sodium Chondroitin Sulfate (porcine; 5500 Mw) Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Polysorbate 20 Methyl Salicylate Rosmarinus Officinalis Flowering Top Carbomer 940

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-22

Description

Camphor ………………. 6% Menthol …………….…. 4%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Aid for temporary local relief of minor pain in muscles or joints.

Dosage and Administration

DIRECTIONS:

Adults and Children over 12 years of age:

Apply a small amount on the affected area.

Massage in circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

Description

Camphor ………………. 6% Menthol …………….…. 4%

Section 50565-1

If swallowed, 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 occur again within a few days

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7

Use only as directed

Do not bandage tightly or use with a heating pad

Avoid contact with eyes and mucous membranes

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

A transient burning sensation or redness may occur upon application but generally disappears in several days

If you experience an allergic reaction, discontinue use and consult a physician

Do not expose the area treated with product to heat or direct sunlight.

Section 51727-6

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Triethanolamine, Arnica Montana Flower Extract, Polysorbate 20, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).

Section 53414-9

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor ………………. 6%

Menthol …………….…. 4%

Other Information

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Question Or Comments?

Call: +1-787-421-6423

Ay Bendito Thermoactive Cream


Structured Label Content

Indications and Usage (34067-9)

Aid for temporary local relief of minor pain in muscles or joints.

Dosage and Administration (34068-7)

DIRECTIONS:

Adults and Children over 12 years of age:

Apply a small amount on the affected area.

Massage in circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If swallowed, 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 occur again within a few days

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7 (50567-7)

Use only as directed

Do not bandage tightly or use with a heating pad

Avoid contact with eyes and mucous membranes

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

A transient burning sensation or redness may occur upon application but generally disappears in several days

If you experience an allergic reaction, discontinue use and consult a physician

Do not expose the area treated with product to heat or direct sunlight.

Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Triethanolamine, Arnica Montana Flower Extract, Polysorbate 20, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).

Section 53414-9 (53414-9)

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor ………………. 6%

Menthol …………….…. 4%

Other Information (OTHER INFORMATION)

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Question Or Comments? (QUESTION OR COMMENTS?)

Call: +1-787-421-6423

Ay Bendito Thermoactive Cream (AY BENDITO THERMOACTIVE CREAM)


Advanced Ingredient Data


Raw Label Data

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