Osmoflex-101

Osmoflex-101
SPL v7
SPL
SPL Set ID 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e
Route
TOPICAL
Published
Effective Date 2022-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.3 g)
Inactive Ingredients
Acrylamide Tricaprylin Caprylyl Glycol Cetyl Alcohol Chondroitin Sulfate (bovine) Water Glucosamine Sulfate Glyceryl Stearate Citrate Isohexadecane Hydrogenated Soybean Lecithin Magnesium Sulfate Heptahydrate Dimethyl Sulfone Polyoxyl 100 Stearate Phenoxyethanol Polyisobutylene (1200000 Mw) Polysorbate 20 Polysorbate 80 Alcohol Shea Butter Sorbic Acid Stearic Acid Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-16

Description

Menthol 1.30%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 1.30%

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Warnings

For External Use Only

Questions

Call 1-866-984-3054

Directions

  • 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
  • massage a generous amount to affected area until absorbed.
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
Drug Facts

Menthol 1.30%

Other Information

  • each gram contains magnesium 6.6 mg
  • store and use at room temperature 20°-25° C (68°-77° F)
  • tamper resistant-do not use if seal under cap is broken or missing.
Inactive Ingredients

acrylamide/sodium acryloyldimethyl taurate copolymer, caprylic/capric triglyceride, caprylyl glycol, cetyl alcohol, chondroitin sulfate, deionized water, glucosamine sulfate, glycerin, glycerol stearate, isohexadecane, lecithin, magnesium sulfate heptahydrate (epsom salt), methylsulfonylmethane (msm), peg-100, stearate, phenoxyethanol, polyacrylate 13, polyisobutene, polysorbate 20, polysorbate 80, sd alcohol, shea butter, sorbic acid, stearic acid, xanthan gum

Osmoflex Product Label

OsmoFlex ™

Pain Relieving Cream Menthol 1.3%

Net Wt 4 oz (113.4g)

NET WT 16 OZ (453.6 g)

NET WT 32 OZ (964.3 g)

Dist. by: Seablue Vitamins, LLC • 211 North Locksley Drive • Lafayette, LA 70508

www.seabluevitamins.com

res

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
  • use only as directed
Stop Use and Ask A Doctor

  • if conditions worsen or if symptoms persist for more that 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation.

If pregnant or breast feedingconsult a doctor 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 immediately.


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical Analgesic

Warnings

For External Use Only

Questions

Call 1-866-984-3054

Directions

  • 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
  • massage a generous amount to affected area until absorbed.
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
Drug Facts

Menthol 1.30%

Other Information

  • each gram contains magnesium 6.6 mg
  • store and use at room temperature 20°-25° C (68°-77° F)
  • tamper resistant-do not use if seal under cap is broken or missing.
Inactive Ingredients

acrylamide/sodium acryloyldimethyl taurate copolymer, caprylic/capric triglyceride, caprylyl glycol, cetyl alcohol, chondroitin sulfate, deionized water, glucosamine sulfate, glycerin, glycerol stearate, isohexadecane, lecithin, magnesium sulfate heptahydrate (epsom salt), methylsulfonylmethane (msm), peg-100, stearate, phenoxyethanol, polyacrylate 13, polyisobutene, polysorbate 20, polysorbate 80, sd alcohol, shea butter, sorbic acid, stearic acid, xanthan gum

Osmoflex Product Label (OsmoFlex product label)

OsmoFlex ™

Pain Relieving Cream Menthol 1.3%

Net Wt 4 oz (113.4g)

NET WT 16 OZ (453.6 g)

NET WT 32 OZ (964.3 g)

Dist. by: Seablue Vitamins, LLC • 211 North Locksley Drive • Lafayette, LA 70508

www.seabluevitamins.com

res

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
  • use only as directed
Stop Use and Ask A Doctor

  • if conditions worsen or if symptoms persist for more that 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation.

If pregnant or breast feedingconsult a doctor before use.

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

Keep out of reach of children.

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


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Raw Label Data

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