AK47 MENTHOL COOLING- menthol cooling cream

AK47 MENTHOL COOLING by

Drug Labeling and Warnings

AK47 MENTHOL COOLING by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol

5%

STOP USE

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

Keep out of reach of children if swallowed, get medical help or contact a poison control center right away

PURPOSE

Topical Analgesic

QUESTIONS

Questions or Comments

info@ak47painrelief.com

WHEN USING

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

INDICATIONS & USAGE

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.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

COOLING CREAM LABEL

COOLING CREAM BOX

INGREDIENTS AND APPEARANCE

AK47 MENTHOL COOLING 
menthol cooling cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-522
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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-522-01	1 in 1 BOX	07/20/2020
1	NDC: 76348-522-04	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	07/20/2020

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-522)