OsmoFlex by Sarati International, Inc. OSMOFLEX- menthol cream

OsmoFlex by

Drug Labeling and Warnings

OsmoFlex by is a Otc medication manufactured, distributed, or labeled by Sarati International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

OSMOFLEX 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67676-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67676-101-01	113.4 g in 1 TUBE; Type 0: Not a Combination Product	01/01/1993
2	NDC: 67676-101-04	453.6 g in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2016
3	NDC: 67676-101-03	964.3 g in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/1993

Labeler - Sarati International, Inc. (160219770)

Registrant - Sarati International, Inc. (160219770)

Establishment
Name	Address	ID/FEI	Business Operations
Sarati International, Inc.		160219770	manufacture(67676-101)