AK4 7 Menthol Warming Cream

AK47 Menthol Warming by

Drug Labeling and Warnings

AK47 Menthol Warming by is a Otc medication manufactured, distributed, or labeled by CROSSTOWN CONCEPTS CORPORATION, RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AK47 MENTHOL WARMING- menthol cream 
CROSSTOWN CONCEPTS CORPORATION

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 Warming Cream

Active Ingredients

Menthol 5 percent

Purpose

Topical Analgesic

Uses: for temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

When using this product: Do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin do not use heating pads or other heating devices.

Warnings

For external use only

Avoid contact with eyes and sensitive areas

Stop use and ask a doctor if:

condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, seek medical help or contact a poison control center right away

Directions

adults and children 12 years of age and older

  • apply liberally to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary

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), Capsicum Frutescens Fruit Extract, 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

Questions

info@ak47painrelief.com

BOX OF 10PACKETTE

AK47 MENTHOL WARMING 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 90078-575
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
OLIVE OIL (UNII: 6UYK2W1W1E)  
CORN OIL (UNII: 8470G57WFM)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TABASCO PEPPER (UNII: J1M3NA843L)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
PINENE (UNII: 996299PUKB)  
TERPINEOL (UNII: R53Q4ZWC99)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MYRCENE (UNII: 3M39CZS25B)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
WITCH HAZEL (UNII: 101I4J0U34)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
SHEA BUTTER (UNII: K49155WL9Y)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-7 (UNII: Z95S6G8201)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 90078-575-1010 in 1 BOX08/13/202008/15/2022
1NDC: 90078-575-044 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 finalpart34808/13/202008/15/2022
Labeler - CROSSTOWN CONCEPTS CORPORATION (009543155)
Registrant - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(90078-575)

Revised: 8/2022