AK4 7 Menthol Cooling Pain Relief Cream

Drug Details [pdf]

AK47 MENTHOL COOLING- menthol cooling 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 Cooling Pain Relief Cream

Menthol

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.

COOLING CREAM LABEL

COOLING CREAM BOX

AK47 MENTHOL COOLING
menthol cooling cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90078-522
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g in 112 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 90078-522-01	1 in 1 BOX	07/20/2020	08/15/2022
1	NDC: 90078-522-04	112 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/20/2020	08/15/2022

Labeler - CROSSTOWN CONCEPTS CORPORATION (009543155)

Registrant - RENU LABORATORIES, INC. (945739449)

Name	Address	ID/FEI	Business Operations
Establishment
RENU LABORATORIES, INC.		945739449	manufacture(90078-522)

Revised: 8/2022

Document Id: e6ec00e6-b21e-f4ae-e053-2a95a90a5077

Set id: ad3f0adc-c465-f920-e053-2a95a90ad295

Version: 2

Effective Time: 20220823

AK4 7 Menthol Cooling Pain Relief Cream

AK47 MENTHOL COOLING by

Drug Labeling and Warnings

Drug Details [pdf]

AK4 7 Menthol Cooling Pain Relief Cream

Directions