Label: AK47 COOLING ROLL-ON- menthol roll-on liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76348-570-01, 76348-570-03 - Packager: Renu Laboratories, Inc.
- 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 August 6, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients:
Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).
- QUESTIONS
- STATEMENT OF IDENTITY
- LABEL AND BOX
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INGREDIENTS AND APPEARANCE
AK47 COOLING ROLL-ON
menthol roll-on liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-570 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.05 g in 84 g Inactive Ingredients Ingredient Name Strength TERPINEOL (UNII: R53Q4ZWC99) CANNABIDIOL (UNII: 19GBJ60SN5) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) PEPPERMINT OIL (UNII: AV092KU4JH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARYOPHYLLENE (UNII: BHW853AU9H) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) ISOPROPYL ALCOHOL (UNII: ND2M416302) WITCH HAZEL (UNII: 101I4J0U34) SODIUM BENZOATE (UNII: OJ245FE5EU) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) WATER (UNII: 059QF0KO0R) GRAPEFRUIT (UNII: O82C39RR8C) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MYRCENE (UNII: 3M39CZS25B) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-PINENE, (+)- (UNII: H6CM4TWH1W) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-570-01 1 in 1 BOX 06/01/2020 1 NDC:76348-570-03 84 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2020 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-570)