AK47 COOLING ROLL-ON- menthol roll-on liquid 
Renu Laboratories, Inc.

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 Cooling Roll-On Pain Relief

Active ingredient: Menthol 1.25%

Purpose Topical Analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients:

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).

Questions? Comments?

info@CBDdispensaryshop.com

AK4 7 TM

Cooling Roll-On

Pain Relief

LABEL AND BOX

AK47 LABEL AND PRODUCT BOX

AK47 box

label AK47

AK47 COOLING ROLL-ON 
menthol roll-on liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-570
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.05 g  in 84 g
Inactive Ingredients
Ingredient NameStrength
TERPINEOL (UNII: R53Q4ZWC99)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WITCH HAZEL (UNII: 101I4J0U34)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
WATER (UNII: 059QF0KO0R)  
GRAPEFRUIT (UNII: O82C39RR8C)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MYRCENE (UNII: 3M39CZS25B)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-PINENE, (+)- (UNII: H6CM4TWH1W)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-570-011 in 1 BOX06/01/2020
1NDC:76348-570-0384 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2020
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-570)

Revised: 8/2020
Document Id: ac366e60-24a5-0fd3-e053-2a95a90adde8
Set id: ac9ba695-afa3-118f-e053-2a95a90a8168
Version: 1
Effective Time: 20200806
 
Renu Laboratories, Inc.