Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d580982f-dda6-4b03-bf84-342b9f2c6d93
Route
TOPICAL
Published
Effective Date 2024-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mg)
Inactive Ingredients
Octyldodecanol Petrolatum Isopropyl Myristate High Density Polyethylene Diisostearyl Malate Shea Butter Candelilla Wax Vinylpyrrolidone/hexadecene Copolymer Eucalyptus Oil Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Tocopherol .alpha.-tocopherol Acetate Aluminum Oxide Limonene, (+)- Aluminum Hydroxide Calcium Sodium Borosilicate Calcium Aluminum Borosilicate Silicon Dioxide Honey Centella Asiatica Triterpenoids Dimethicone Stannic Oxide Butylated Hydroxytoluene Citric Acid Monohydrate Titanium Dioxide Ferric Oxide Red D&c Red No. 7 Mica Fd&c Yellow No. 6 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-01

Description

Menthol 0.5%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 0.5%

Use
  • for the temporary relief of pain associated with fever blisters and cold sores
Section 51945-4

Warnings

For external use only

Directions
  • for adult use only: apply to affected area not more than 3 to 4 times daily
Active Ingredient

Menthol 0.5%

Questions Or Comments?

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

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

Polybutene, Octyldodecanol, Petrolatum, Isopropyl Myristate, Polyethylene, Ozokerite, Diisostearyl Malate, Butyrospermum Parkii (shea) Butter, Euphorbia Cerifera (candelilla) Wax, Vp/hexadecene Copolymer, Eucalyptus Globulus Leaf Oil, Pentaerythrityl Tetra Di T Butyl Hydroxyhydrocinnamate, Tocopherol, Tocopheryl Acetate, Alumina, Limonene, Aluminum Hydroxide, Synthetic Fluorphlogopite, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, Silica, Honey, Centella Asiatica Extract, Dimethicone, Tin Oxide, Bht, citric Acid, Titanium Dioxide, Iron Oxides, Red 22 Lake, Red 7, Red 28 Lake, Mica, Yellow 5 Lake, Yellow 6 Lake, Blue 1 Lake, Carmine


Structured Label Content

Use
  • for the temporary relief of pain associated with fever blisters and cold sores
Section 51945-4 (51945-4)

Purpose

External analgesic

Warnings

For external use only

Directions
  • for adult use only: apply to affected area not more than 3 to 4 times daily
Active Ingredient (Active ingredient)

Menthol 0.5%

Questions Or Comments? (Questions or comments?)

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
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.

Polybutene, Octyldodecanol, Petrolatum, Isopropyl Myristate, Polyethylene, Ozokerite, Diisostearyl Malate, Butyrospermum Parkii (shea) Butter, Euphorbia Cerifera (candelilla) Wax, Vp/hexadecene Copolymer, Eucalyptus Globulus Leaf Oil, Pentaerythrityl Tetra Di T Butyl Hydroxyhydrocinnamate, Tocopherol, Tocopheryl Acetate, Alumina, Limonene, Aluminum Hydroxide, Synthetic Fluorphlogopite, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, Silica, Honey, Centella Asiatica Extract, Dimethicone, Tin Oxide, Bht, citric Acid, Titanium Dioxide, Iron Oxides, Red 22 Lake, Red 7, Red 28 Lake, Mica, Yellow 5 Lake, Yellow 6 Lake, Blue 1 Lake, Carmine (polybutene, octyldodecanol, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopherol, tocopheryl acetate, alumina, limonene, aluminum hydroxide, synthetic fluorphlogopite, calcium sodium borosilicate, calcium aluminum borosilicate, silica, honey, centella asiatica extract, dimethicone, tin oxide, BHT, citric acid, titanium dioxide, iron oxides, red 22 lake, red 7, red 28 lake, mica, yellow 5 lake, yellow 6 lake, blue 1 lake, carmine)


Advanced Ingredient Data


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