drug facts

drug facts
SPL v3
SPL
SPL Set ID 2f7b8221-66f6-4aed-8359-318cfc656a72
Route
topical
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5 mg)
Inactive Ingredients
petrolatum shea butter tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-10-01

Purpose

External analgesic

Description

Menthol 0.5%


Medication Information

Warnings

For external use only

Purpose

External analgesic

Directions

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

Inactive Ingredients

octyldodecanol, polybutene, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, penaerythrityl tetra-di-t-butyl hydroxyhydrocinamate, tocopherol, tocopheryl acetate, limonene, honey, centella asiatica extract

Description

Menthol 0.5%

Use

for the temporary relief of pain associated with fever blisters and cold sores

Section 51945-4

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.


Structured Label Content

Warnings

For external use only

Purpose

External analgesic

Directions

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

Inactive Ingredients (Inactive ingredients)

octyldodecanol, polybutene, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, penaerythrityl tetra-di-t-butyl hydroxyhydrocinamate, tocopherol, tocopheryl acetate, limonene, honey, centella asiatica extract

Use

for the temporary relief of pain associated with fever blisters and cold sores

Section 51945-4 (51945-4)

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.


Advanced Ingredient Data


Raw Label Data

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