85110-116-04

85110-116-04
SPL v1
SPL
SPL Set ID 42fab525-b0a5-97fb-e063-6394a90aec6c
Route
TOPICAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (11 g) Menthol (16 g)
Inactive Ingredients
Glycerin Water Petrolatum White Wax Mentha Piperita (peppermint) Oil Tapioca Starch Eugenia Caryophyllus (clove) Bud Oil Curcuma Longa (turmeric) Root Eugenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-28

Description

Camphor 11% Menthol 16%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 11% Menthol 16%

Use

for temporary local relief of minor pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

Warnings
  • For external use only.
  • Ask a doctor before use if you have redness over affected area.
Directions

Adults and Children over 12 years of age:

  • Apply a small amount on the affected area.
  • Massage in a 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°F - 86°F (15°C - 30°C)

Active Ingredients

Camphor 11%

Menthol 16%

Inactive Ingredients

Petrolatum, Cera Alba, Mentha Piperita (Peppermint) Oil, Tapioca Starch, Eugenia Caryophyllus Bud Oil, Curcuma Longa (Turmeric) Root Extract, Glycerin, Water (Aqua), Eugenol.

Paingel Unguento Jar

Questions Or Comments?

Contact us +1-307-533-7345

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.
  • 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.
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.
Keep Out of Reach of Children.

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

If Pregnant Or Breast – Feeding

Ask a health professional before use.


Structured Label Content

Use

for temporary local relief of minor pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

Purpose

Topical Analgesic

Warnings
  • For external use only.
  • Ask a doctor before use if you have redness over affected area.
Directions

Adults and Children over 12 years of age:

  • Apply a small amount on the affected area.
  • Massage in a 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°F - 86°F (15°C - 30°C)

Active Ingredients (Active ingredients)

Camphor 11%

Menthol 16%

Inactive Ingredients (Inactive ingredients)

Petrolatum, Cera Alba, Mentha Piperita (Peppermint) Oil, Tapioca Starch, Eugenia Caryophyllus Bud Oil, Curcuma Longa (Turmeric) Root Extract, Glycerin, Water (Aqua), Eugenol.

Paingel Unguento Jar (PAINGEL UNGUENTO JAR)

Questions Or Comments? (Questions or comments?)

Contact us +1-307-533-7345

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.
  • 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.
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.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

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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