Drug Facts - Signature Care Cold And Hot Medicated

Drug Facts - Signature Care Cold And Hot Medicated
SPL v4
SPL
SPL Set ID 88f59f95-0a7c-458c-949c-0dff16ad94e4
Route
TOPICAL
Published
Effective Date 2015-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Carboxymethylcellulose Sodium, Unspecified Form Castor Oil Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Hydroxypropyl Cellulose, Unspecified Kaolin Polyvinyl Alcohol, Unspecified Polyacrylic Acid (250000 Mw) Water Sorbitol Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-09-01

Description

Menthol 5%

Purpose

Menthol - Topical analgesic


Medication Information

Purpose

Menthol - Topical analgesic

Description

Menthol 5%

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • arthritis
  • simple backache
  • strains
  • sprains
  • bursitis
  • tendonitis
  • bruises
  • cramps
Warnings

For external use only

Directions
  • adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
  • children under 12 years: ask a doctor
  • for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.
Active Ingredient

Menthol 5%

Inactive Ingredients

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Principal Display Panel
When Using This Product
  • use only as directed
  • avoid contact with eyes or on mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad
Stop Use and Ask A Doctor If
  • excessive redness or irritation is present
  • condition worsens
  • pain persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

Structured Label Content

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • arthritis
  • simple backache
  • strains
  • sprains
  • bursitis
  • tendonitis
  • bruises
  • cramps
Purpose

Menthol - Topical analgesic

Warnings

For external use only

Directions
  • adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
  • children under 12 years: ask a doctor
  • for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.
Active Ingredient (Active ingredient)

Menthol 5%

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Principal Display Panel
When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes or on mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • excessive redness or irritation is present
  • condition worsens
  • pain persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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