Kofal Max Power Menthol 1.25% (wp) (da)

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (1.25 g)

Inactive Ingredients

Nonoxynol-9 Polysorbate 20 Tea Tree Oil Dmdm Hydantoin Isopropyl Alcohol Camphor (synthetic) Arnica Montana Flower Carbomer 940 Water Alcohol Eucalyptus Oil Cannabis Sativa Seed Oil Trolamine Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2023-06-10 Until 2027-10-01

Medication Information

Description

Active ingredient Purpose Menthol 1.25% .................. External analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Do Not

apply on wounds or irritated skin
bandage tightly

Section 55105-1

Active ingredient	Purpose
Menthol 1.25% ..................	External analgesic

Warnings

For external use only. Avoid contact with the eyes.

Directions

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: do not use, consult a doctor

Distributed By:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Other Information

store between 59°- 86°F (15 - 30°C)
do not use if clear seal over jar is broken, torn or missing

Inactive Ingredients

alcohol, arnica montana flower, cannabis sativa (hemp) seed oil, camphor, carbomer 940, DMDM hydantoin, eucalyptus oil, isopropyl alcohol, nonoxynol-9, polysorbate 20, propylene glycol, tea tree oil, trolamine, water

Principal Display Panel

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

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

Stop Use and Ask Doctor Immediately If

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Do Not (Do not)

apply on wounds or irritated skin
bandage tightly

Section 55105-1 (55105-1)

Active ingredient	Purpose
Menthol 1.25% ..................	External analgesic

Warnings

For external use only. Avoid contact with the eyes.

Directions

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: do not use, consult a doctor

Distributed By: (Distributed by:)

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Other Information (Other information)

store between 59°- 86°F (15 - 30°C)
do not use if clear seal over jar is broken, torn or missing

Inactive Ingredients (Inactive ingredients)

alcohol, arnica montana flower, cannabis sativa (hemp) seed oil, camphor, carbomer 940, DMDM hydantoin, eucalyptus oil, isopropyl alcohol, nonoxynol-9, polysorbate 20, propylene glycol, tea tree oil, trolamine, water

Principal Display Panel

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask Doctor Immediately If (Stop use and ask doctor immediately if)

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

[{"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CANNABIS SATIVA SEED OIL", "unii": "69VJ1LPN1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

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