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Osmoflex - Medication Information

Product NDC Code 67676-101
Drug Name

Osmoflex

Type Brand
Active Ingredients
Menthol 1.3 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 436147,
1050947
Application Number M017
Labeler Name Sarati International, Inc.
Packages
Package NDC Code Description
67676-101-01 113.4 g in 1 tube (67676-101-01)
67676-101-03 964.3 g in 1 bottle (67676-101-03)
67676-101-04 453.6 g in 1 bottle (67676-101-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts Active Ingredient Menthol 1.30%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Purpose

Information about the drug product’s indications for use.
Purpose Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
OsmoFlex MENTHOL 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 MENTHOL MENTHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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 Sarati OsmoFlex 1 Sarati OsmoFlex 2

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on wounds or damaged skin with a heating pad

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Call 1-866-984-3054

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes or mucous membranes do not bandage tightly use only as directed

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For External Use Only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API