Extra Strength Pain Relief Cream

Extra Strength Pain Relief Cream
SPL v2
SPL
SPL Set ID c6264c23-5803-324c-e053-2a95a90a9719
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
Safflower Oil Cannabis Sativa Seed Oil Peppermint Oil Glyceryl Caprylate Caprylhydroxamic Acid Propanediol Water Glycerin Boswellia Serrata Resin Oil Sclerocarya Birrea Seed Oil Argan Oil Medium-chain Triglycerides Cetyl Alcohol Diheptyl Succinate Camphor (natural) Cetostearyl Alcohol Stearyl Alcohol Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Cetearyl Glucoside .alpha.-tocopherol Acetate Sodium Hydroxide Xanthan Gum

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:

  • strains
  • bruises
  • simple backache
  • arthritis
  • sprains
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 symptoms persist for more than 7 days or clear up and occur again wtihin 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

Extra Strength Pain Relief Cream

Instant Cooling

With 10% Menthol

95% Natural Ingredients

4 FL OZ / 118 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 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor
Active Ingredient

Menthol 10%

Inactive Ingredients

Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide


Structured Label Content

Uses

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

  • strains
  • bruises
  • simple backache
  • arthritis
  • sprains
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 symptoms persist for more than 7 days or clear up and occur again wtihin 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

Extra Strength Pain Relief Cream

Instant Cooling

With 10% Menthol

95% Natural Ingredients

4 FL OZ / 118 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 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor
Active Ingredient (Active ingredient)

Menthol 10%

Inactive Ingredients (Inactive ingredients)

Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide


Advanced Ingredient Data


Raw Label Data

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