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

AK47 MENTHOL WARMING 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90078-575
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90078-575-10	10 in 1 BOX	08/13/2020	08/15/2022
1	NDC: 90078-575-04	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	08/15/2022

Labeler - CROSSTOWN CONCEPTS CORPORATION (009543155)

Registrant - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(90078-575)

Revised: 8/2022

Document Id: e6ec015d-379f-4cdb-e053-2a95a90a7d5b

34390-5

Set id: adb71f3f-f424-3534-e053-2995a90a5116

Version: 2

Effective Time: 20220823