Krt Packet

Krt Packet
SPL v1
SPL
SPL Set ID fc73dde9-9df4-beca-e053-6394a90aaf0d
Route
TOPICAL
Published
Effective Date 2023-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-05-24

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

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 product use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

Section 53414-9

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

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 Ingredient

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 Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Laureth Sulfate, 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)

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 product use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

Section 53414-9 (53414-9)

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

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 (Package label)

Active Ingredient

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 Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Laureth Sulfate, Stearic Acid, Triethanolamine.


Advanced Ingredient Data


Raw Label Data

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