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

Sagely Naturals

Pain Relief Roll-On

Instant Cooling

With 10% Menthol

95% Natural Ingredients

2 FL OZ / 60 ML

PAIN RELIEF ROLL-ON
menthol liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/02/2021

Labeler - Sagely Enterprises Inc. (117049032)

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