Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2fbe23b7-23a3-4f0b-bc08-0205256f5d68
Route
TOPICAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (160 mg)
Inactive Ingredients
Alcohol Glycerin Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-14

Description

Menthol 16%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 16%

Uses
  • relieves minor pain of muscles and joins associated with:
    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
Warnings

For external use only

Flammable:

  • Do not use while smoking or near heat or flame
Directions

- shake well

  • adults and children 12 years of age and older:
    • spray product on area not more than 1 to 3 times daily
  • children under 12 years of age
    • ask a doctor
Do Not Apply
  • to wounds or damaged, broken or irritated skin. - Do not allow contact with eyes or mucous membranes.
Active Ingredient

Menthol 16%

Other Information
  • May cause staining. Use with caution when spraying near fabric and unprotected surfaces
Inactive Ingredients

Glycerin, Propylene Glycol, SDA 40-2 Alcohol, Water.

When Using This Product
  • keep out of eyes
  • do not bandage tightly
  • do not use with a heating pad
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than a week
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 a Poison Control Center right away.
Principal Display Panel 118 G Can Label

NATURE'S OIL

16% Menthol

Spray

Net Wt 4 oz (113g)

Manufactured For:

Nature's Oil

1800 Miller Parkway

Streetsboro, Ohio 44241

www.NaturesOil.com


Structured Label Content

Uses
  • relieves minor pain of muscles and joins associated with:
    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
Purpose

Topical analgesic

Warnings

For external use only

Flammable:

  • Do not use while smoking or near heat or flame
Directions

- shake well

  • adults and children 12 years of age and older:
    • spray product on area not more than 1 to 3 times daily
  • children under 12 years of age
    • ask a doctor
Do Not Apply (Do not apply)
  • to wounds or damaged, broken or irritated skin. - Do not allow contact with eyes or mucous membranes.
Active Ingredient (Active ingredient)

Menthol 16%

Other Information (Other information)
  • May cause staining. Use with caution when spraying near fabric and unprotected surfaces
Inactive Ingredients (Inactive ingredients)

Glycerin, Propylene Glycol, SDA 40-2 Alcohol, Water.

When Using This Product (When using this product)
  • keep out of eyes
  • do not bandage tightly
  • do not use with a heating pad
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than a week
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 a Poison Control Center right away.
Principal Display Panel 118 G Can Label (Principal Display Panel - 118 g Can Label)

NATURE'S OIL

16% Menthol

Spray

Net Wt 4 oz (113g)

Manufactured For:

Nature's Oil

1800 Miller Parkway

Streetsboro, Ohio 44241

www.NaturesOil.com


Advanced Ingredient Data


Raw Label Data

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