ARNICA ICE COOLING- camphor menthol gel

Arnica Ice Cooling by

Drug Labeling and Warnings

Arnica Ice Cooling by is a Otc medication manufactured, distributed, or labeled by Kyron Laboratories (pty) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Avoid contact with open wounds, eyes or mucus membrains. If excessive skin irritation develops. Wash with water and discontinue use.
Consult a doctor if injuries are severe.

PURPOSE

Muscular relief cooling gel

ACTIVE INGREDIENT

ARNICA OIL
CAMPHOR
WITCH HAZEL
MENTHOL CRYSTALS

INACTIVE INGREDIENT

CARBOPOL 990
WATER
POLYSORBATE 80
METHYL HYDROXYBENZOATE
PROPYL HYDROXYBENZOATE
TRIETHANOLAMINE 85%

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, animals and uniformed persons.
Although this remedy has been extensively tested under a wide variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek advice and notify the registration holder.
This medicine has not been evaluated by the MCC.
This medicine is not intended to diagnose, treat, cure or prevent any disease.

DOSAGE & ADMINISTRATION

Use only as directed

INDICATIONS & USAGE

indications and usage

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA ICE COOLING 
camphor menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70674-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	6.0 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70674-001-01	475 mg in 1 JAR; Type 0: Not a Combination Product	05/24/2016
2	NDC: 70674-001-02	100 mg in 1 PACKAGE; Type 0: Not a Combination Product	05/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/23/2016

Labeler - Kyron Laboratories (pty) Ltd (568517155)

Establishment
Name	Address	ID/FEI	Business Operations
Kyron Laboratories (pty) Ltd		568517155	manufacture(70674-001)