85110-610-04

85110-610-04
SPL v1
SPL
SPL Set ID 42fa2397-b61a-3b16-e063-6294a90a5fed
Route
TOPICAL
Published
Effective Date 2025-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Camphor (synthetic) (6 g)
Inactive Ingredients
Diazolidinyl Urea C13-14 Isoparaffin Xanthan Gum Stearyl Alcohol Polysorbate 20 Methylparaben Propylparaben Laureth-7 Triethanolamine Cetearyl Alcohol Water Glycerin Cetyl Alcohol Stearic Acid Glyceryl Stearate Dimethicone Caprylic/capric Triglyceride Polyacrylamide (1500 Mw) Rosmarinus Officinalis Whole Propylene Glycol Paraffinum Liquidum Alcohol Polysorbate 60 .alpha.-tocopherol Acetate

Identifiers & Packaging

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

Description

Camphor ………………. 6% Menthol …………….…. 10%

Purpose

External Analgesic


Medication Information

Warnings and Precautions
  • For external use only.
  • Use only as directed.
  • Do not bandage tightly.
  • Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
Purpose

External Analgesic

Description

Camphor ………………. 6% Menthol …………….…. 10%

Use

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Section 50565-1

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

Section 51727-6

Water (Aqua), Alcohol Denat, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Polysorbate 60, Polyacrylamide, Propylene Glycol, Tocopheryl Acetate, Stearyl Alcohol, Polysorbate 20, C13-14 Isoparaffin, Xanthan Gum, Laureth-7, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

Directions

Adults and children over 12 years of age

  • apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.
  • Wash hands with soap and water after use.

Children under 12 years of age. Do not use unless directed by a doctor.

Other Information

Store at room temperature 15° - 30°C (59° - 86°F)

Active Ingredients

Camphor ………………. 6%

Menthol …………….…. 10%

Question Or Comments?

Contact us +1-307-533-7345

When Using This Product
  • Avoid contact with eyes, mucous membranes, rashes.
  • Do not apply to wounds or damaged skin.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.
Ask A Doctor Before Use If

you have redness over affected area.

Paingel Topical Cream Tube

Paingel Topical Cream Sachet

If Pregnant of Breast Feeding

Ask a health professional before use.


Structured Label Content

Use

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings and Precautions (34071-1)
  • For external use only.
  • Use only as directed.
  • Do not bandage tightly.
  • Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
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, Paraffinum Liquidum, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Polysorbate 60, Polyacrylamide, Propylene Glycol, Tocopheryl Acetate, Stearyl Alcohol, Polysorbate 20, C13-14 Isoparaffin, Xanthan Gum, Laureth-7, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

Purpose

External Analgesic

Directions

Adults and children over 12 years of age

  • apply a thin layer to the affected area and rub gently not more than 3 to 4 times daily.
  • Wash hands with soap and water after use.

Children under 12 years of age. Do not use unless directed by a doctor.

Other Information (Other information)

Store at room temperature 15° - 30°C (59° - 86°F)

Active Ingredients (Active ingredients)

Camphor ………………. 6%

Menthol …………….…. 10%

Question Or Comments? (QUESTION OR COMMENTS?)

Contact us +1-307-533-7345

When Using This Product (When using this product)
  • Avoid contact with eyes, mucous membranes, rashes.
  • Do not apply to wounds or damaged skin.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.
Ask A Doctor Before Use If (Ask a doctor before use if)

you have redness over affected area.

Paingel Topical Cream Tube (PAINGEL TOPICAL CREAM TUBE)

Paingel Topical Cream Sachet (PAINGEL TOPICAL CREAM SACHET)

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

Ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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