Label: AK47 MENTHOL WARMING- menthol warming cream
- NDC Code(s): 76348-521-01, 76348-521-04
- 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 3, 2020
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- ACTIVE INGREDIENT
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- PURPOSE
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INACTIVE INGREDIENT
Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract 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 WARMING
menthol warming creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-521 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.6 g in 112 g Inactive Ingredients Ingredient Name Strength LINALOOL, (+)- (UNII: F4VNO44C09) CARYOPHYLLENE (UNII: BHW853AU9H) PINENE (UNII: 996299PUKB) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CANNABIDIOL (UNII: 19GBJ60SN5) LIMONENE, (+)- (UNII: GFD7C86Q1W) STEARIC ACID (UNII: 4ELV7Z65AP) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) COCONUT OIL (UNII: Q9L0O73W7L) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) WITCH HAZEL (UNII: 101I4J0U34) CORN OIL (UNII: 8470G57WFM) MYRCENE (UNII: 3M39CZS25B) TERPINEOL (UNII: R53Q4ZWC99) PEG-100 STEARATE (UNII: YD01N1999R) WHITE WAX (UNII: 7G1J5DA97F) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) SHEA BUTTER (UNII: K49155WL9Y) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) OLIVE OIL (UNII: 6UYK2W1W1E) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TABASCO PEPPER (UNII: J1M3NA843L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-521-01 1 in 1 BOX 07/20/2020 1 NDC:76348-521-04 112 g in 1 JAR; 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 07/20/2020 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-521)