Pain Relief Roll-On: Package Insert and Label Information

PAIN RELIEF ROLL-ON- menthol liquid
Sagely Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

1
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2
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PAIN RELIEF ROLL-ON
menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82075-420
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
LAVENDER OIL
PEPPERMINT OIL
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
ARNICA MONTANA
GLYCERIN
LAURYL GLUCOSIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
BOSWELLIA SERRATA RESIN OIL
PROPANEDIOL
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
MICROCRYSTALLINE CELLULOSE
POLYGLYCERYL-6 CAPRYLATE
POLYGLYCERYL-4 CAPRATE
POLYGLYCERYL-6 RICINOLEATE
CAMPHOR (NATURAL)
ALOE VERA LEAF
XANTHAN GUM
WATER
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)
COCO-CAPRYLATE
GLYCERYL STEARATE CITRATE
GLYCERYL MONOSTEARATE
DIHEPTYL SUCCINATE
FYTIC ACID
CAPRYLYL GLYCERYL ETHER
CAPRYLHYDROXAMIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82075-420-20 1 CYLINDER in 1 CARTON contains a CYLINDER
1 60 g in 1 CYLINDER This package is contained within the CARTON (82075-420-20)
2 NDC:82075-420-05 1 CYLINDER in 1 CARTON contains a CYLINDER
2 51 g in 1 CYLINDER This package is contained within the CARTON (82075-420-05)
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 Operations
Verde Cosmetic Labs, LLC 080656433 manufacture (82075-420)

Revised: 11/2021 Sagely Enterprises Inc.

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