SPL v5
SPL
SPL Set ID b22c7999-52d5-25c3-e053-2a95a90a01f5
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (25 mg)
Inactive Ingredients
Isopropyl Alcohol Water Carbomer Interpolymer Type A (55000 Cps) Propylene Glycol Edetate Disodium .alpha.-tocopherol Trolamine Polysorbate 80 Methylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

MENTHOL 2.5%

Purpose

TOPICAL ANALGESIC


Medication Information

Purpose

TOPICAL ANALGESIC

Description

MENTHOL 2.5%

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains
Section 51945-4
  • original strenghth
  • Topical analgesic
Warnings

For external use only

Questions

www.drspharmacyusa.com

Directions
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Active Ingredient

MENTHOL 2.5%

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients



vitamin E, propylene glycol, polysorbate 80, water, isopropyl alcohol, carbomer interpolymer type A, EDTA , methylparaben, propylparaben

When Using This Product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask Your Doctor

Stop use and ask your doctor if:

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Keep Out of Reach of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses (USES)

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains
Section 51945-4 (51945-4)
  • original strenghth
  • Topical analgesic
Purpose (PURPOSE)

TOPICAL ANALGESIC

Warnings (WARNINGS)

For external use only

Questions

www.drspharmacyusa.com

Directions
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Active Ingredient (ACTIVE INGREDIENT)

MENTHOL 2.5%

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients



vitamin E, propylene glycol, polysorbate 80, water, isopropyl alcohol, carbomer interpolymer type A, EDTA , methylparaben, propylparaben

When Using This Product (When using this product)

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask Your Doctor (Stop use and ask your doctor)

Stop use and ask your doctor if:

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
Keep Out of Reach of Children (Keep out of reach of children)



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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