Drug Facts - Mentholatum Pain Relieving

Drug Facts - Mentholatum Pain Relieving
SPL v3
SPL
SPL Set ID 0056b952-9870-485a-9f35-f985472875a9
Route
TOPICAL
Published
Effective Date 2018-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (60 mg) Salicylic Acid (200 mg)
Inactive Ingredients
Carboxypolymethylene Lanolin Oil Mineral Oil Polysorbate 60 Water Sorbitan Monostearate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Menthol 6% Methyl salicylate 20%

Purpose

Menthol - Topical analgesic Methyl salicylate - Topical analgesic


Medication Information

Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Description

Menthol 6% Methyl salicylate 20%

Uses

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

  • arthritis
  • simple backache
  • strains
  • sprains
Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Active Ingredients

Menthol 6%

Methyl salicylate 20%

Inactive Ingredients

carbomer, lanolin oil, polysorbate 60, purified water, sorbitan monosterate, trolamine

When Using This Product
  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or to damaged skin
  • do not bandage tightly
  • do not use with a heating pad, other heat sources, or right after a shower/bath
  • do not use in combination with other external analgesic products
Stop Use and Ask A Doctor If
  • condition worsens
  • excessive irritation, burning or discomfort of the skin develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding,

ask a healthcare 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
Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Directions
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Active Ingredients (Active ingredients)

Menthol 6%

Methyl salicylate 20%

Inactive Ingredients (Inactive ingredients)

carbomer, lanolin oil, polysorbate 60, purified water, sorbitan monosterate, trolamine

When Using This Product (When using this product)
  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or to damaged skin
  • do not bandage tightly
  • do not use with a heating pad, other heat sources, or right after a shower/bath
  • do not use in combination with other external analgesic products
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • excessive irritation, burning or discomfort of the skin develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a healthcare 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 (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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