MODESA MOISTURIZING HAND ANTIBACTERIAL- benzethonium chloride liquid 
Family Dollar Services Inc.

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.

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Drug Facts

Active ingredient

Benzethonium chloride 0.10%

Purpose

Antibacterial

Use

for hand washing to decrease bacteria on the skin

Warnings

For external use only

When using this product

■ avoid contact with the eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if


■ irritation and redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ apply onto wet hands, lather and rinse thoroughly

Inactive ingredients

water, lauramine oxide, cetrimonium chloride, cocamidopropylamine oxide, cocamide MEA, glycerin, PEG-150 distearate, sodium chloride, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, FD&C blue no.1, D&C red no.33

Package Label

Package label

MODESA  MOISTURIZING HAND ANTIBACTERIAL
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-431
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-431-75221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2017
2NDC:55319-431-401180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/18/2017
Labeler - Family Dollar Services Inc. (024472631)

Revised: 12/2017
Document Id: 6141e157-0068-4f58-e053-2991aa0ad75f
Set id: 6141e1ac-4f44-35b1-e053-2991aa0a6895
Version: 1
Effective Time: 20171226
 
Family Dollar Services Inc.