AK4 7 Blue Menthol Cream

AK47 MENTHOL COOLING by

Drug Labeling and Warnings

AK47 MENTHOL COOLING 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 COOLING- 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 Blue Menthol Cream

Menthol

5%

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, get medical help or contact a poison control center right away

Topical Analgesic

Questions or Comments

info@ak47painrelief.com

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.

For external use only

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

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

Directions

adults and children 12 years of age and older

• apply generously to affected area
• massage into painful area until thoroughy 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), 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.

AK47 BLUE

BOX ART

AK47 BLUE

LABEL ART

AK47 MENTHOL COOLING 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90078-577
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
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)
EMU OIL (UNII: 344821WD61)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LINALOOL, (+)- (UNII: F4VNO44C09)
CARYOPHYLLENE (UNII: BHW853AU9H)
PINENE (UNII: 996299PUKB)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CANNABIDIOL (UNII: 19GBJ60SN5)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90078-577-01	1 in 1 BOX	02/15/2021	08/15/2022
1	NDC: 90078-577-04	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	02/01/2021	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(90078-577)

Revised: 8/2022

Document Id: e6ea9932-23f9-5d6c-e053-2a95a90aa267

34390-5

Set id: ba0e7d40-5ed9-10a9-e053-2995a90ab483

Version: 2

Effective Time: 20220823