Medication Guide App

OsmoFlex

Dosage form: cream
Ingredients: MENTHOL 1.3g in 100g
Labeler: Sarati International, Inc.
NDC Code: 67676-101

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Menthol 1.3%

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 damages skin or with a heating pad

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
  • use only as directed

If pregnant or breast feeding consult a doctor before use.

Stop Use and Ask A Doctor

Stop and ask a doctor if conditions worsen or if symptoms persist for more that 7 days, or if symptoms clear up and occur again within a few days, or if there is excessive skin irritation.

When Using This Product

As a doctor before use if you have

  • redness over affected area
  • kidney disease
  • a magnesium-restricted diet
  • shellfish allergy

Adults 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.

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center immediately

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 Label

OsmoFlex Pain Relieving Cream  Menthol 1.3%  Net Wt 4 oz (113.4g)

Dist: Panacea Cream Products, LLC  1720 Kaliste Saloom Road, STE B-1 Lafayette, LA 70508 USA www.osmoflex.com

OSMOFLEX 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67676-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLAMIDE 
TRICAPRYLIN 
CAPRYLYL GLYCOL  
CETYL ALCOHOL 
CHONDROITIN SULFATE (BOVINE) 
WATER 
GLUCOSAMINE SULFATE 
GLYCERIN 
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 
Packaging
#Item CodePackage Description
1NDC:67676-101-01113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1993
Labeler - Sarati International, Inc. (160219770)
Registrant - Sarati International, Inc. (160219770)
Establishment
NameAddressID/FEIOperations
Sarati International, Inc.160219770manufacture

Revised: 12/2010
 
Sarati International, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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