OP 6 MENTHOL COOLING ROLL ON- menthol liquid

OP 6 MENTHOL COOLING ROLL ON by

Drug Labeling and Warnings

OP 6 MENTHOL COOLING ROLL ON by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 5 percent

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

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

• bruises
• sprains
• arthritis
• strains

WARNINGS

Warnings

For external use only

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 with heating pads or other heating devices.

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.

DOSAGE & ADMINISTRATION

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, consulta a doctor.

INACTIVE INGREDIENT

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

Questions? Comments?

www.HempforLifeWellness.com

PRINCIPAL DISPLAY PANEL

PRODUCT LABEL AND PRODUCT BOX

INGREDIENTS AND APPEARANCE

OP 6 MENTHOL COOLING ROLL ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-670
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-670-01	1 in 1 BOX	08/02/2021
1	NDC: 76348-670-03	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	08/02/2021

Labeler - RENU LABORATORIES, INC. (945739449)

Registrant - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-670)