AK47 MENTHOL COOLING CREAM PACKET- menthol cream 
RENU LABORATORIES, INC.

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.

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AK4 7 MENTHOL COOLING CREAM PACKET

Active Ingredient

Menthol 5 %

Purpose

Topical Analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with

When using this product

Do not bandage tightly

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

info@ak47painrelief.com

For external use only.

Cooling Pack

AND PRODUCT BOX

BOX OF 10

BOX OF 10 COOLING PACKETS

AK47 MENTHOL COOLING CREAM PACKET 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-576
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-576-1010 in 1 BOX08/13/2020
1NDC:76348-576-044 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/13/2020
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-576)

Revised: 8/2020
Document Id: adb83c12-6e2a-8c70-e053-2a95a90a2761
Set id: adb83c12-6e29-8c70-e053-2a95a90a2761
Version: 1
Effective Time: 20200825
 
RENU LABORATORIES, INC.