AK4 7 Cooling Roll-On Pain Relief

AK47 Cooling Roll-On by

Drug Labeling and Warnings

AK47 Cooling Roll-On 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 COOLING ROLL-ON- menthol roll on liquid 
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 Cooling Roll-On Pain Relief

Menthol 5%

Topical Analgesic

Uses

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

• bruises
• sprains
• arthritis
• strains

Warnings

For external use only.

When using this product

• Do not bandage tightly
• avoid contact with eyes
• do not apply to wounds or damaged skin
• do not use with heating pads or other heating devices.

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.

Directions

• Adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain.
• Children under 12 years of age: do not use, consult a doctor.

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,

Hydroxethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate,

Virginiana Hamamelis (Witch Hazel).

AK4 7 TM

Cooling Roll-On

Pain Relief

Questions

Comments

Email info@ak47painrelief.com

AK47 LABEL AND PRODUCT BOX

AK47 COOLING ROLL-ON 
menthol roll on liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90078-523
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.2 g  in 84 g

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MYRCENE (UNII: 3M39CZS25B)
PEPPERMINT OIL (UNII: AV092KU4JH)
GRAPEFRUIT (UNII: O82C39RR8C)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WITCH HAZEL (UNII: 101I4J0U34)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
TERPINEOL (UNII: R53Q4ZWC99)
WATER (UNII: 059QF0KO0R)
.ALPHA.-PINENE, (+)- (UNII: H6CM4TWH1W)
CANNABIDIOL (UNII: 19GBJ60SN5)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARYOPHYLLENE (UNII: BHW853AU9H)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90078-523-01	1 in 1 BOX	08/03/2020	08/15/2022
1	NDC: 90078-523-03	84 g in 1 APPLICATOR; 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	08/03/2020	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(90078-523)

Revised: 8/2022

Document Id: e6ec166e-b440-1645-e053-2a95a90aa703

34390-5

Set id: acb51966-8f79-ba8e-e053-2a95a90a12be

Version: 2

Effective Time: 20220823