Pain Relief Cream

Pain Relief Cream
SPL v3
SPL
SPL Set ID c624fa53-c565-9114-e053-2a95a90acca3
Route
TOPICAL
Published
Effective Date 2021-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Glycerin Boswellia Serrata Resin Oil Safflower Oil Cetearyl Glucoside Xanthan Gum .alpha.-tocopherol Acetate Camphor (natural) Cannabis Sativa Seed Oil Argan Oil Glyceryl Caprylate Caprylhydroxamic Acid Propanediol Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Cetostearyl Alcohol Diheptyl Succinate Stearyl Alcohol Water Cetyl Alcohol Medium-chain Triglycerides Sclerocarya Birrea Seed Oil Peppermint Oil Sodium Hydroxide

Identifiers & Packaging

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

Description

Menthol 5%

Purpose

Menthol 5%.................Topical analgesic


Medication Information

Purpose

Menthol 5%.................Topical analgesic

Description

Menthol 5%

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 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 Cream

Instant Cooling

With 5% 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 5%

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 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 Cream

Instant Cooling

With 5% 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 5%.................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 5%

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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