drug facts - mentholatum deep heating rub

drug facts - mentholatum deep heating rub
SPL v9
SPL
SPL Set ID f5684158-0d83-4031-b493-5422ddc73e78
Route
topical
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (80 mg) salicylic acid (300 mg)
Inactive Ingredients
glyceryl monostearate isoceteth-20 poloxamer 407 water sodium lauryl sulfate sorbitan monostearate trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1992-12-15

Purpose

Menthol - External analgesic Methyl salicylate - External analgesic

Description

Menthol 8% Methyl salicylate 30%


Medication Information

Warnings

For external use only

Uses

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

  • arthritis
  • strains
  • simple backache
  • sprains
Purpose

Menthol - External analgesic

Methyl salicylate - External analgesic

Directions
  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor
Inactive Ingredients

glyceryl stearate, isoceteh-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Description

Menthol 8% Methyl salicylate 30%

Principal Display Panel
Questions?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

www.mentholatum.com

Active Ingredients

Menthol 8%

Methyl salicylate 30%

When Using This Product
  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with 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

Warnings

For external use only

Uses

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

  • arthritis
  • strains
  • simple backache
  • sprains
Purpose

Menthol - External analgesic

Methyl salicylate - External analgesic

Directions
  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor
Inactive Ingredients (Inactive ingredients)

glyceryl stearate, isoceteh-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Principal Display Panel
Questions?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

www.mentholatum.com

Active Ingredients (Active ingredients)

Menthol 8%

Methyl salicylate 30%

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 damaged skin
  • do not bandage tightly
  • do not use with 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, ask a healthcare 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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