Pain Relief Roll-on

Pain Relief Roll-on
SPL v2
SPL
SPL Set ID c6283ab0-8244-b8f3-e053-2a95a90a7bef
Route
TOPICAL
Published
Effective Date 2021-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-07-02

Description

Menthol 10%

Purpose

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


Medication Information

Purpose

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

Description

Menthol 10%

Uses

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

  • arthritis
  • sprains
  • muscle strains
  • bruises
Section 50565-1

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

Section 50566-9

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.
Section 50567-7

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50570-1

Do not use

  • on wounds, or damaged, broken, or irritated skin
  • with a heating pad
Section 51945-4

Sagely Naturals

Pain Relief Roll-On

Instant Cooling

With 10% Menthol

95% Natural Ingredients

2 FL OZ / 60 ML

Section 53414-9

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

Warnings

For external use only.

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.
Active Ingredient

Menthol 10%

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


Structured Label Content

Uses

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

  • arthritis
  • sprains
  • muscle strains
  • bruises
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • on wounds, or damaged, broken, or irritated skin
  • with a heating pad
Section 51945-4 (51945-4)

Sagely Naturals

Pain Relief Roll-On

Instant Cooling

With 10% Menthol

95% Natural Ingredients

2 FL OZ / 60 ML

Section 53414-9 (53414-9)

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

Purpose

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

Warnings

For external use only.

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.
Active Ingredient (Active ingredient)

Menthol 10%

Inactive Ingredients (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


Advanced Ingredient Data


Raw Label Data

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