OSMOFLEX- menthol cream 
Sarati International, Inc.

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OsmoFlex-101

Drug Facts
Active Ingredient

Menthol 1.30%

Purpose

Topical Analgesic

Uses

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

Warnings

For External Use Only

Do not use

When using this product

Stop Use and Ask A Doctor

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.

Directions

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

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

Sarati OsmoFlex 1

Sarati OsmoFlex 2

res

OSMOFLEX 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67676-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLAMIDE (UNII: 20R035KLCI)  
TRICAPRYLIN (UNII: 6P92858988)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
WATER (UNII: 059QF0KO0R)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALCOHOL (UNII: 3K9958V90M)  
SHEA BUTTER (UNII: K49155WL9Y)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67676-101-01113.4 g in 1 TUBE; Type 0: Not a Combination Product05/16/2016
2NDC:67676-101-04453.6 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
3NDC:67676-101-03964.3 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/16/2016
Labeler - Sarati International, Inc. (160219770)
Registrant - Sarati International, Inc. (160219770)
Establishment
NameAddressID/FEIBusiness Operations
Sarati International, Inc.160219770manufacture(67676-101)

Revised: 10/2023
Document Id: 08b4632c-2421-6046-e063-6294a90a1527
Set id: 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e
Version: 7
Effective Time: 20231027
 
Sarati International, Inc.