Label: ARNICA ICE COOLING- camphor menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70674-001-01, 70674-001-02 - Packager: Kyron Laboratories (pty) Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 23, 2016
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- WARNINGS
- PURPOSE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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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
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARNICA ICE COOLING
camphor menthol gelProduct 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)