Osmoflex Cream
FDA Label NDC 67676-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sarati International, Inc. for the product Osmoflex (NDC 67676-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient

Menthol 1.30%

Purpose

Topical Analgesic

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

Do Not Use

  • on wounds or damaged skin
  • with a heating pad

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 feeding consult 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.

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.

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

Questions

Call 1-866-984-3054

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.

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

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