72524-091-03

72524-091-03
SPL v2
SPL
SPL Set ID 3e552afc-9305-8825-e063-6294a90a1afe
Route
TOPICAL
Published
Effective Date 2025-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-10

Description

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


Medication Information

Warnings and Precautions

For external use only.

Description

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

Use

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

Section 50565-1

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

Section 51727-6

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Cannabis Sativa (Hemp) Seed Oil, 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), FD&C Yellow No. 5.

Section 55105-1

Topical Analgesic

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).

Active Ingredients

Camphor ………………. 6%

Menthol …………….…. 4%

Question Or Comments?

Call: +1-787-421-6423

When Using This Product
  • 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.
Ay Bendito Hemp Sachet

Ay Bendito Hemp Roll On

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.

If Pregnant of Breast Feeding

Ask a health professional before use.


Structured Label Content

Use

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 51727-6 (51727-6)

Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Cannabis Sativa (Hemp) Seed Oil, 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), FD&C Yellow No. 5.

Section 55105-1 (55105-1)

Topical Analgesic

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).

Active Ingredients (Active ingredients)

Camphor ………………. 6%

Menthol …………….…. 4%

Question Or Comments? (QUESTION OR COMMENTS?)

Call: +1-787-421-6423

When Using This Product (When using this product)
  • 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.
Ay Bendito Hemp Sachet (AY BENDITO - HEMP SACHET)

Ay Bendito Hemp Roll On (AY BENDITO - HEMP ROLL-ON)

Stop Use and Ask A Doctor If (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.

If Pregnant of Breast Feeding (If pregnant of breast feeding)

Ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)