MODESA- ethyl alcohol gel

Modesa by

Drug Labeling and Warnings

Modesa by is a Otc medication manufactured, distributed, or labeled by Shanghai Weierya Daily Chemicals Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients

blue 1, carbomer 940, corn

starch, glycerin, lactose,

microcrystalline cellulose,

propylene glycol, red 33,

sucrose, triethanolamine,

water

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 65 % v/v

PURPOSE

Purpose   Antimicrobial

WARNINGS

Warnings

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

INDICATIONS & USAGE

Uses

hand sanitizer to help reduce bacteria on skin

DOSAGE & ADMINISTRATION

Directions   Put a dime sized drop onto hands

and rub together briskly until dry.

DO NOT USE

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

STOP USE

Stop use and ask a doctor

if irritation, excessive redness or

rash develops.

OTHER SAFETY INFORMATION

Flammable. Keep away from

fire or flame.

STORAGE AND HANDLING

Other Information

Store below 110 F ( 43 C )

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MODESA  
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58194-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA (vanilla sugar)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58194-022-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/25/2015

Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Weierya Daily Chemicals Factory		420359333	manufacture(58194-022)