SOLID ROOTS ROLL-ON RELIEF- menthol 3 percent liquid

SOLID ROOTS ROLL-ON RELIEF by

Drug Labeling and Warnings

SOLID ROOTS ROLL-ON RELIEF 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 3 percent

PURPOSE

Topical Anesthetic

INDICATIONS & USAGE

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

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

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

DOSAGE & ADMINISTRATION

Adults and children twelve years of age and older,

apply to affected area no more than ten times a day as needed for pain

children under twelve years of age do not use, consult a doctor

INACTIVE INGREDIENT

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Menth Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Hamamelis Virginiana (Witch Hazel)

QUESTIONS

Questions? Comments ?

HELLO@AUTHENTICBLENDS.COM

AUTHENTIC BLENDS, LLC

HAVERTOWN, PA 19083

PRODUCT MULTI-LAYER LABEL Page 1 of 3 Page 2 of 3 Page 3 of 3

LABEL IS A MULTI-LAYER. PAGE 1, PAGE 2 AND PAGE 3 ALL PART OF THE PEEL BACK LABEL

INGREDIENTS AND APPEARANCE

SOLID ROOTS ROLL-ON RELIEF 
menthol 3 percent liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-481
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.84 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
GRAPEFRUIT (UNII: O82C39RR8C)
WATER (UNII: 059QF0KO0R)
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)
PEPPERMINT OIL (UNII: AV092KU4JH)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MAGNESIUM OROTATE (UNII: GI96W46M5A)
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
ARNICA MONTANA (UNII: O80TY208ZW)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CANNABIDIOL (UNII: 19GBJ60SN5)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
WITCH HAZEL (UNII: 101I4J0U34)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-481-01	28 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/13/2022

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-481)