72524-005-06

72524-005-06
SPL v9
SPL
SPL Set ID 835abc66-680f-be06-e053-2a91aa0a309e
Route
TOPICAL
Published
Effective Date 2023-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (6 g) Menthol (4 g)
Inactive Ingredients
Polysorbate 20 Rosmarinus Officinalis Whole Sodium Chondroitin Sulfate (porcine; 5500 Mw) Arnica Montana Flower Fd&c Blue No. 1 Carbomer 940 Alcohol Mineral Oil Glycerin Trolamine Methylchloroisothiazolinone/methylisothiazolinone Mixture Methyl Salicylate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-18

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:

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, Arnica Montana Flower Extract, Triethanolamine, Carbomer, Methyl Salicylate, Glucosamine Sulfate, Sodium Chondroitin 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 Lotion Sachet


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:

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, Arnica Montana Flower Extract, Triethanolamine, Carbomer, Methyl Salicylate, Glucosamine Sulfate, Sodium Chondroitin 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 Lotion Sachet (AY BENDITO THERMOACTIVE LOTION SACHET)


Advanced Ingredient Data


Raw Label Data

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