Signature Care Menthol 4% Rollon 2.5 Oz

Signature Care Menthol 4% Rollon 2.5 Oz
SPL v2
SPL
SPL Set ID 27d3cb47-a6c7-5b7a-e063-6394a90a056f
Route
TOPICAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Carbomer 940 Glycerin .alpha.-tocopherol Acetate Aloe Vera Leaf Fd&c Blue No. 1 Camellia Sinensis Leaf Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Water Camphor (natural) Arnica Montana Flower Melissa Officinalis Leaf Boswellia Serrata Extract Arctium Lappa Whole Calendula Officinalis Flower Isopropyl Myristate Aminomethyl Propanol Isopropyl Alcohol Ilex Paraguariensis Leaf Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Menthol 4%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Menthol 4%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Label

Warnings

For External use only

keep away from fire or flame

Directions

Adults and children 2 years of age and older

  • rub a thin film over affected area not more than 3 to 4 times daily

Children under 2 years of age:

  • ask a doctor
  • wash hands after use with cool water
Active Ingredient

Menthol 4%

Other Information
  • store at 68-77 F (20-25 C)
  • ​store in a cool dry place away from direct sunlight
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C BLUE NO.1, FD&C YELLOW NO.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl myristate, Melissa Officinalis Leaf Extract,

Methyl Methacrylate Crosspolymer,Tocopheryl Acetate, Water

Questions and Comments

Call 1-866-326-1313

When Using This Product

use only as directed

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or devise
Stop Use and Ask A Doctor If

  • you experience pain, swelling, or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age.
If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children and Pets

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Label

Purpose

Pain Relieving Gel

Warnings

For External use only

keep away from fire or flame

Directions

Adults and children 2 years of age and older

  • rub a thin film over affected area not more than 3 to 4 times daily

Children under 2 years of age:

  • ask a doctor
  • wash hands after use with cool water
Active Ingredient

Menthol 4%

Other Information (Other information)
  • store at 68-77 F (20-25 C)
  • ​store in a cool dry place away from direct sunlight
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C BLUE NO.1, FD&C YELLOW NO.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl myristate, Melissa Officinalis Leaf Extract,

Methyl Methacrylate Crosspolymer,Tocopheryl Acetate, Water

Questions and Comments (Questions and comments)

Call 1-866-326-1313

When Using This Product (When using this product)

use only as directed

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or devise
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • you experience pain, swelling, or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age.
If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away


Advanced Ingredient Data


Raw Label Data

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