SPL v1
SPL
SPL Set ID c9f0a39a-feda-200f-e053-2995a90aa888
Route
TOPICAL
Published
Effective Date 2021-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g)
Inactive Ingredients
Phenoxyethanol Caprylyl Glycol Cetyl Alcohol Chamomile Orange Oil, Cold Pressed Coconut Oil Laureth-4 Sage Stearic Acid Trolamine Creatine Dimethicone 200 Eucalyptus Globulus Leaf Butylene Glycol Glyceryl Stearate Se Water Carbomer 940

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-04

Description

Menthol, 3.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol, 3.0%

Uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Section 50565-1

If pregnant or breast-feeding, ask a health professional before use.

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

Section 50566-9

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 redness is present irritation develeps

Section 50567-7

When using this prodcut use only as directed avoid contact with eyes or mucous membranes do not apply to wounds or damaged skin

Warnings

for external use only

Directions:

Adults and children over 12 years: apply to affected area massage into painful area until throughly absorbed into skin repeat as necessary, but no more than 4 time daily

Children 12 years or younger: ask a doctor

Package Label

Active Incredient

Menthol, 3.0%

Inactive Ingredients

​Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus aurantium Dulcis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Stearic Acid, Triethanolamine.


Structured Label Content

Uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Section 50565-1 (50565-1)

If pregnant or breast-feeding, ask a health professional before use.

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

Section 50566-9 (50566-9)

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 redness is present irritation develeps

Section 50567-7 (50567-7)

When using this prodcut use only as directed avoid contact with eyes or mucous membranes do not apply to wounds or damaged skin

Purpose

Topical analgesic

Warnings

for external use only

Directions:

Adults and children over 12 years: apply to affected area massage into painful area until throughly absorbed into skin repeat as necessary, but no more than 4 time daily

Children 12 years or younger: ask a doctor

Package Label

Active Incredient

Menthol, 3.0%

Inactive Ingredients (Inactive ingredients)

​Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus aurantium Dulcis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Stearic Acid, Triethanolamine.


Advanced Ingredient Data


Raw Label Data

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