72524-604-04

72524-604-04
SPL v8
SPL
SPL Set ID bbf0ca84-2800-d222-e053-2995a90ad8f3
Route
TOPICAL
Published
Effective Date 2023-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

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 42228-7

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

Section 50565-1

KEEP OUT OF REACH OF CHILDEN:

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

Section 50566-9

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

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 Gel


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 42228-7 (42228-7)

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDEN:

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

Section 50566-9 (50566-9)

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

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 Gel (AY BENDITO THERMOACTIVE GEL)


Advanced Ingredient Data


Raw Label Data

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