Flexsport Roll On - Ms 15% (wp)(da)

Flexsport Roll On - Ms 15% (wp)(da)
SPL v3
SPL
SPL Set ID bf8de3da-7628-6112-e053-2995a90a8e16
Route
TOPICAL
Published
Effective Date 2021-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 g)
Inactive Ingredients
Capsaicin Propylene Glycol Water Isopropyl Alcohol Menthol Polysorbate 20 Alpha-tocopherol Acetate Camphor (synthetic) Polyacrylic Acid (250000 Mw) Dmdm Hydantoin Arnica Montana Flower Trolamine Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-04-04 Until 2027-03-01

Description

Active ingredient Purpose Menthol 16% .................... Topical analgesic


Medication Information

Description

Active ingredient Purpose Menthol 16% .................... Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Section 55105-1
Active ingredient Purpose
Menthol 16% .................... Topical analgesic

Warnings

For external use only. Avoid contact with the eyes.

Flammable: keep away from fire or flame.

Directions
  • use only as directed
  • adults and children over 12 years: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Other Information
  • store at temperatures not exceeding 15°–30°C (59°– 86°F)
  • avoid excessive heat and humidity
Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water

Questions Or Comments?

1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com

Principal Display Panel

Topical Analgesic Liquid

FlexSport

Pain Relief

ROLL-ON

  • Muscle & Joint Pain
  • Backaches
  • Arthritis

3 fl oz (89 mL)

When Using This Product
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged, broken or irritated skin
Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed,get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
Section 55105-1 (55105-1)
Active ingredient Purpose
Menthol 16% .................... Topical analgesic

Warnings

For external use only. Avoid contact with the eyes.

Flammable: keep away from fire or flame.

Directions
  • use only as directed
  • adults and children over 12 years: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Other Information (Other information)
  • store at temperatures not exceeding 15°–30°C (59°– 86°F)
  • avoid excessive heat and humidity
Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water

Questions Or Comments? (Questions or Comments?)

1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com

Principal Display Panel

Topical Analgesic Liquid

FlexSport

Pain Relief

ROLL-ON

  • Muscle & Joint Pain
  • Backaches
  • Arthritis

3 fl oz (89 mL)

When Using This Product (When using this product)
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged, broken or irritated skin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed,get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)