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.

Active Ingredient

Camphor ………………. 6%

Menthol …….…………. 4%

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.

Other Information

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

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

Question Or Comments?

Call: +1-787-421-6423

Ay Bendito Thermoactive Gel


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Camphor ………………. 6%

Menthol …….…………. 4%

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.

Other Information (OTHER INFORMATION)

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

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

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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