72524-641-04

Drug Facts

Composition & Product

Active Ingredients

Camphor (natural) (6 g) Menthol, (+)- (4 g)

Inactive Ingredients

Trolamine Mineral Oil Sodium Chondroitin Sulfate (porcine; 5500 Mw) Water Glycerin Arnica Montana Flower Water Methylchloroisothiazolinone Methylisothiazolinone Polysorbate 20 Methyl Salicylate Rosmarinus Officinalis Flowering Top Fd&c Blue No. 1 Carbomer 940 Glucosamine Sulfate

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-22

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

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 doctor

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 Tube

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)

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 doctor

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 Tube (AY BENDITO THERMOACTIVE CREAM TUBE)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Aid for temporary local relief of minor pain in muscles or joints.", "34068-7": "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.", "34071-1": "For external use only.", "50565-1": "If swallowed, get medical help or contact a Poison Control Center right away.", "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.", "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 doctor Do not expose the area treated with product to heat or direct sunlight.", "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).", "53414-9": "IF PREGNANT OR BREAST – FEEDING: Ask a health professional before use.", "55105-1": "Topical Analgesic", "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"}