Label: AK47 MENTHOL COOLING CREAM PACKET- menthol cream
- NDC Code(s): 76348-576-04, 76348-576-10
- 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 25, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
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INACTIVE INGREDIENT
Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Olus Oil (vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid.
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INGREDIENTS AND APPEARANCE
AK47 MENTHOL COOLING CREAM PACKET
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-576 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.2 g in 4 g Inactive Ingredients Ingredient Name Strength MYRCENE (UNII: 3M39CZS25B) LINALOOL, (+)- (UNII: F4VNO44C09) WHITE WAX (UNII: 7G1J5DA97F) COCONUT OIL (UNII: Q9L0O73W7L) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PEPPERMINT OIL (UNII: AV092KU4JH) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) OLIVE OIL (UNII: 6UYK2W1W1E) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) CANNABIDIOL (UNII: 19GBJ60SN5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) WITCH HAZEL (UNII: 101I4J0U34) SHEA BUTTER (UNII: K49155WL9Y) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) LIMONENE, (+)- (UNII: GFD7C86Q1W) CARYOPHYLLENE (UNII: BHW853AU9H) PINENE (UNII: 996299PUKB) TERPINEOL (UNII: R53Q4ZWC99) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CORN OIL (UNII: 8470G57WFM) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-576-10 10 in 1 BOX 08/13/2020 1 NDC:76348-576-04 4 g in 1 PACKET; 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 08/13/2020 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-576)