SPL v1
SPL
SPL Set ID 06f4e017-93d2-40fb-8965-93d9c2a915e7
Route
TOPICAL
Published
Effective Date 2019-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (3 1) Menthol (10 g)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Ascorbic Acid Glucan Endo-1,3-.alpha.-glucosidase Agn1 Boswellia Serrata Whole Ceramide Ng Cetearyl Olivate Cetyl Alcohol Matricaria Chamomilla Leaf Cucumis Sativus Whole Distearyldimonium Chloride Gluconolactone Glyceryl Stearate Se Glycerin Sunflower Oil Lactic Acid, L- Magnesium Sulfate Anhydrous Tea Tree Oil 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 Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-22

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, cramps, bruises, and sprains.

Do Not

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

Section 42229-5

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Made in USA

54641-008-01

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 there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51945-4

Pain Cream

Pain Relief

  • Long Lasting
  • Invisible
  • No smell

3.4 oz (96 g)

  • Fast and Long-Lasting Pain Relief
  • Smooth, Non-Sticky, Pleasant Smell
  • Invsible Relief for Hours

Flex24(r)

Recover Naturally

Caution

• Discontinue use if excessive irritation of the skin develops

• Avoid contact with the eyes and mucous membranes

• Arthritis: If pain persists for 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 or older: Apply to affected area as and when required.

• Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) 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.

• Children under 2 years old: consult a doctor

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Active Ingredients

Menthol, 10%

Camphor, 3%

Questions/comments?

www.FLEX24.com/paincream

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 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol


Structured Label Content

Uses

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

Do Not (Do not)

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

Section 42229-5 (42229-5)

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Made in USA

54641-008-01

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 there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51945-4 (51945-4)

Pain Cream

Pain Relief

  • Long Lasting
  • Invisible
  • No smell

3.4 oz (96 g)

  • Fast and Long-Lasting Pain Relief
  • Smooth, Non-Sticky, Pleasant Smell
  • Invsible Relief for Hours

Flex24(r)

Recover Naturally

Caution

• Discontinue use if excessive irritation of the skin develops

• Avoid contact with the eyes and mucous membranes

• Arthritis: If pain persists for 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 or older: Apply to affected area as and when required.

• Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) 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.

• Children under 2 years old: consult a doctor

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Active Ingredients

Menthol, 10%

Camphor, 3%

Questions/comments? (Questions/Comments?)

www.FLEX24.com/paincream

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 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol


Advanced Ingredient Data


Raw Label Data

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