PAIN RELIEF ROLL-ON- menthol liquid

Pain Relief Roll-On by

Drug Labeling and Warnings

Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Sagely Enterprises Inc., Verde Cosmetic Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 10%

Purpose

Menthol 10%.................Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• arthritis
• sprains
• muscle strains
• bruises

Warnings

For external use only.

Do not use

• on wounds, or damaged, broken, or irritated skin
• with a heating pad

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

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.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use only as directed

Adults and children over 12 years:

• apply a thin layer to affected area
• massage into painful area
• repeat as necessary, but no more than 3 to 4 times daily
• Children 12 years or younger: ask a doctor.

Inactive ingredients

Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco-Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Diheptyl Succinate, Glycerin, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Microcrystalline Cellulose, Cellulose Gum, Phytic Acid, Leuconostoc/Radish Root Ferment Filtrate, Boswellia Serrata Resin Extract, Polyglyceryl-6 Caprylate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Cocoate, Polyglyceryl-6 Ricinoleate, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Camphor, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Lavender (Lavandula Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid

PRINCIPAL DISPLAY PANEL

Sagely Naturals

Pain Relief Roll-On

Instant Cooling

With 10% Menthol

95% Natural Ingredients

2 FL OZ / 60 ML

INGREDIENTS AND APPEARANCE

PAIN RELIEF ROLL-ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82075-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
ARNICA MONTANA (UNII: O80TY208ZW)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7)
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
POLYGLYCERYL-6 RICINOLEATE (UNII: 8X57R183N7)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
FYTIC ACID (UNII: 7IGF0S7R8I)
CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82075-420-20	1 in 1 CARTON	07/02/2021
1		60 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 82075-420-05	1 in 1 CARTON	11/19/2021
2		51 g in 1 CYLINDER; 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	07/02/2021

Labeler - Sagely Enterprises Inc. (117049032)

Establishment
Name	Address	ID/FEI	Business Operations
Verde Cosmetic Labs, LLC		080656433	manufacture(82075-420)