OP 6 MENTHOL COOLING ROLL ON- menthol 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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OP 6 MENTHOL COOLING ROLL ON

Active ingredient

Menthol 5 percent

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

Do not bandage tightly

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

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

Questions? Comments?

www.HempforLifeWellness.com

PRODUCT LABEL AND PRODUCT BOX

Label 2 coolingLabel 1_cooling roll-on

OP 6 MENTHOL COOLING ROLL ON 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.2 g  in 84 g
Inactive Ingredients
Ingredient NameStrength
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
WITCH HAZEL (UNII: 101I4J0U34)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
PINENE (UNII: 996299PUKB)  
ARNICA MONTANA (UNII: O80TY208ZW)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
MYRCENE (UNII: 3M39CZS25B)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-670-011 in 1 BOX08/02/2021
1NDC:76348-670-0384 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 finalpart34808/02/2021
Labeler - RENU LABORATORIES, INC. (945739449)
Registrant - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-670)

Revised: 8/2021
Document Id: c9b2e269-9d3c-acc7-e053-2a95a90a0806
Set id: c9b2eddc-691e-e1ed-e053-2a95a90ab87e
Version: 1
Effective Time: 20210802
 
RENU LABORATORIES, INC.