SPL v2
SPL
SPL Set ID 9a7e5861-3ece-46b8-a1b5-b4b633dba185
Route
TOPICAL
Published
Effective Date 2022-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (3 g) Menthol (10 g)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Ascorbic Acid Glucan Endo-1,3-.alpha.-glucosidase Agn1 Boswellia Serrata Whole Ceramide Ng Cetearyl Olivate Cetyl Alcohol Matricaria Chamomilla Cucumis Sativus Whole Distearyldimonium Chloride Gluconolactone Glycerin Helianthus Annuus Whole Lactic Acid Magnesium Sulfate Anhydrous Melaleuca Alternifolia Whole Xanthan Gum Dimethyl Sulfone Ppg-12/smdi Copolymer Vitamin A Saccharide Isomerate Alcohol Denatonium Benzoate Tert-butyl Alcohol Sodium Benzoate Sorbitan Olivate Starch, Tapioca .alpha.-tocopherol Acetate, D- Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-09-29

Description

Menthol, 10% Camphor, 3%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol, 10% Camphor, 3%

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, bruises, and sprains

Do Not

Apply to open wounds, or damaged, broken, or irritated skin

Section 50565-1

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

Section 51945-4

FLEX24

RECOVER NATURALLY

PAIN CREAM

SAMPLE PACK

NET wt. 0.14 oz (3.8g)

Dist: FLEX24, INC.

4020 GALT OCEAN DRIVE, STE. 1607

FORT LAUDERDALE, FL 33308

CALL TOLL FREE 844.4.FLEX24

NDC 73218-001-01

Caution
  • Discontinue use if there is redness or excessive irritation on skin
  • Avoid contact with eyes
  • Arthritis: If pain persists more than 10 days or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately
Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily
  • Children under 2 years old: consult a doctor
  • Tear and apply in a circle of 25 mm diameter to affected area and spread smoothly over the skin with fingers
  • Wash fingers that applied cream with water.  Do not rub eyes with fingers until washed with water
Active Ingredients

Menthol, 10%

Camphor, 3%

Inactive Ingredients

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Stop Use and Ask A Doctor If

conditions worsens or if symptoms persist for more than 7 days


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, bruises, and sprains

Do Not (Do not)

Apply to open wounds, or damaged, broken, or irritated skin

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

FLEX24

RECOVER NATURALLY

PAIN CREAM

SAMPLE PACK

NET wt. 0.14 oz (3.8g)

Dist: FLEX24, INC.

4020 GALT OCEAN DRIVE, STE. 1607

FORT LAUDERDALE, FL 33308

CALL TOLL FREE 844.4.FLEX24

NDC 73218-001-01

Caution
  • Discontinue use if there is redness or excessive irritation on skin
  • Avoid contact with eyes
  • Arthritis: If pain persists more than 10 days or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately
Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily
  • Children under 2 years old: consult a doctor
  • Tear and apply in a circle of 25 mm diameter to affected area and spread smoothly over the skin with fingers
  • Wash fingers that applied cream with water.  Do not rub eyes with fingers until washed with water
Active Ingredients

Menthol, 10%

Camphor, 3%

Inactive Ingredients

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

conditions worsens or if symptoms persist for more than 7 days


Advanced Ingredient Data


Raw Label Data

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