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

Purpose

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

Description

Menthol 10%


Medication Information

Warnings

For external use only.

Uses

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

  • arthritis
  • sprains
  • muscle strains
  • bruises
Purpose

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

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

Description

Menthol 10%

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.

Active Ingredient

Menthol 10%


Structured Label Content

Warnings

For external use only.

Uses

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

  • arthritis
  • sprains
  • muscle strains
  • bruises
Purpose

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

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 (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

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.

Active Ingredient (Active ingredient)

Menthol 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)