72524-092-04

72524-092-04
SPL v1
SPL
SPL Set ID 457d89aa-4a84-94a6-e063-6294a90a20c0
Route
TOPICAL
Published
Effective Date 2025-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (6 g) Menthol (4 g)
Inactive Ingredients
Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Polysorbate 20 Methyl Salicylate Rosmarinus Officinalis Whole Carbomer 940 Mineral Oil Fd&c Yellow No. 5 Alcohol Cannabis Sativa Seed Oil C13-14 Isoparaffin Laureth-7 Trolamine Glucosamine Sulfate Water Glycerin Arnica Montana Flower Sodium Chondroitin Sulfate (porcine; 5500 Mw)

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-20

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.

Description

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

Section 50565-1

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 doctor
  • Do not expose the area treated with product to heat or direct sunlight.
Section 51727-6

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, , Rosmarinus Officinalis (Rosemary) Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Triethanolamine, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090).

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor ………………. 6%

Menthol …………….…. 4%

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.

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 Hemp Oil Gel Jar

Ay Bendito Hemp Oil Gel Tube

If Pregnant Or Breast – Feeding

Ask a health professional before use.


Structured Label Content

Indications and Usage (34067-9)

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

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)
  • 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, Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, , Rosmarinus Officinalis (Rosemary) Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Triethanolamine, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090).

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor ………………. 6%

Menthol …………….…. 4%

Directions (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.

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 Hemp Oil Gel Jar (AY BENDITO - HEMP OIL GEL JAR)

Ay Bendito Hemp Oil Gel Tube (AY BENDITO - HEMP OIL GEL TUBE)

If Pregnant Or Breast – Feeding (If pregnant or breast – feeding)

Ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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