bcbe4032-10b2-6556-e053-2995a90a803b

SPL v3
SPL
SPL Set ID bcbe4032-10b2-6556-e053-2995a90a803b
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 matricaria chamomilla citrus sinensis fruit oil coconut oil laureth-4 salvia officinalis flowering top stearic acid trolamine creatine monohydrate 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

Purpose

Topical analgesic

Description

Menthol, 3.0%


Medication Information

Warnings

for external use only

Uses

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

Purpose

Topical analgesic

Inactive Ingredients

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

Description

Menthol, 3.0%

Section 43683-2

Corrected Section Type

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

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%


Structured Label Content

Warnings

for external use only

Uses

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

Purpose

Topical analgesic

Inactive Ingredients (Inactive ingredients)

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

Section 43683-2 (43683-2)

Corrected Section Type

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

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%


Advanced Ingredient Data


Raw Label Data

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