HERBAL HEALERS MENTHOL WARMING ROLL ON- menthol liquid

Herbal Healers Menthol Warming Roll On by

Drug Labeling and Warnings

Herbal Healers Menthol Warming 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

Menthol 5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Uses for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

WARNINGS

For external use only

WHEN USING

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 of if symptoms persist for more then 7 days or clear p 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 or as directed by your doctor

children under 12 years of age, do not use. Consult a healthcare professional.

INACTIVE INGREDIENT

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Hemp Derived Cannabigerol (CBG) Extract with proprietary terpene blend (Alpha Pinene, Beta Caryophyllene, Myrcene, Limonene, Linalool, Terpinolene), Capsicum frutescens extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Hydroxyethyl Celluose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel).

QUESTIONS

Questions ? www.HerbalHealersCBD.com

STATEMENT OF IDENTITY

HERBAL HEALERS

Menthol WARMING

Pain Relief

Roll-On

PRINCIPAL DISPLAY PANEL

WARMING PAIN RELIEF ROLL-ON LABEL AND BOX

BOX ART

INGREDIENTS AND APPEARANCE

HERBAL HEALERS MENTHOL WARMING ROLL ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-581
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)
LOBELIA INFLATA (UNII: 9PP1T3TC5U)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CANNABIGEROL (UNII: J1K406072N)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-PINENE (UNII: JPF3YI7O34)
LINALOOL, (+)- (UNII: F4VNO44C09)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
CANNABIDIOL (UNII: 19GBJ60SN5)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)
TERPINOLENE (UNII: N9830X5KSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARYOPHYLLENE (UNII: BHW853AU9H)
MYRCENE (UNII: 3M39CZS25B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-581-01	1 in 1 BOX	10/12/2020
1	NDC: 76348-581-03	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	10/12/2020

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-581)