ARNICOOL- menthol cream 
Clinical Resolution Laboratory, Inc.

----------

ARNICOOL

DRUG FACTS

Active Ingredient

Menthol 4%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

Warnings

(For external use only)

Do not use this product if

  • Tamper Evident "Do Not Use...Seal..."label atop the container is broken
  • Pregnant or breastfeeding, ask a health professional before use

When using this product

  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Do not use with heating pad or device

Stop use and ask a doctor if

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reccur.

Keep out of reach of children

In case of accidental overdose or if ingested, contact a doctor or Poison Control Center immediately.

Directions

Other Information

Inactive Ingredients

Water, Arnica Montana Flower Extract, Aloe Barbadensis (Aloe Vera) Leaf Extract, Centella Asiatica Extract, Glycerin, Xanthan Gum, Glucosamine, Methylsulfonylmethane (MSM), Helianthus Annuus (Sunflower) Seed Oil, Dromiceius (Emu) Oil, Pyridoxine Hydrochloride (Vitamin B6), Butyrospermum Parkii (Shea) Butter, Dimethicone, Frankincense Serrata Oil, Lavandula Officinalis (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Tocopherol, Dipotassium Glycyrrhizinate, Glyceryl Stearate / PEG-100 Stearate, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Ethoxydiglycol, Lecithin, Cholesterol, Phenoxyethanol, Disodium EDTA

Package Labeling:

Label3Label4

ARNICOOL 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLUCOSAMINE (UNII: N08U5BOQ1K)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
EMU (UNII: 97P687I7AP)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TEA TREE OIL (UNII: VIF565UC2G)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EUCALYPTUS GUM (UNII: 72T9EZC2VX)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63742-007-0065 g in 1 JAR; Type 0: Not a Combination Product05/15/2018
2NDC:63742-007-01130 g in 1 JAR; Type 0: Not a Combination Product05/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/15/2018
Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 12/2023
Document Id: 0d766155-d1a2-7bf3-e063-6394a90a17b6
Set id: 0289de81-909a-4995-a293-2fa0db565027
Version: 4
Effective Time: 20231226
 
Clinical Resolution Laboratory, Inc.