ARNICOOL by Clinical Resolution Laboratory, Inc. ARNICOOL- menthol cream

ARNICOOL by

Drug Labeling and Warnings

ARNICOOL by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults and children 12 years of age older: Apply liberally to the affected area(s) and continue to massage in thoroughly for 1-2 minutes until it has been absorbed. For best results, apply 2-3 times daily for 2 weeks, then as needed.
• Children under 12 years of age:consult a physician.

Other Information

• Store in room temperature (59~86°F).

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:

INGREDIENTS AND APPEARANCE

ARNICOOL 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-007-00	65 g in 1 JAR; Type 0: Not a Combination Product	05/15/2018
2	NDC: 63742-007-01	130 g in 1 JAR; Type 0: Not a Combination Product	05/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/15/2018

Labeler - Clinical Resolution Laboratory, Inc. (825047942)