RASPBERRY GUAVA ANTIBACTERIAL- alcohol gel 
SEA MARINE ANTIBACTERIAL- alcohol gel 
H2O Plus

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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h2o+™

Drug Facts

Active Ingredient

Alcohol 68%

Purpose

Antibacterial

Uses

  • Decreases bacteria on hands

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

  • Avoid direct contact with eyes
  • Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Rub a dime-sized amount into hands

Inactive ingredients

Aqua/Water/Eau, Glycerin, Aloe Barbadensis Leaf Juice, Cetraria Islandica Extract, Fucus Vesiculosus Extract, Nasturtium Officinale Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Citric Acid, Potassium Sorbate, Sodium Benzoate, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Linalool, CI 14700/ Red 4, CI 17200/Red 33 (090-30360-000)

Questions or comments

1-800-242-2284

Distributed by: H2O Plus, L.L.C. Chicago,
IL 60607

PRINCIPAL DISPLAY PANEL - 37 mL Bottle Label

h2o+™

ANTIBACTERIAL
HAND GEL

RASPBERRY GUAVA

Kills 99.9% of germs. Conditions skin.

37 mL / 1.25 U.S. Fl oz ℮

Principal Display Panel - 37 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 37 mL Bottle Label

h2o+™

ANTIBACTERIAL
HAND GEL

SEA MARINE

Kills 99.9% of germs. Conditions skin.

37 mL / 1.25 U.S. Fl oz ℮

Principal Display Panel - 37 mL Bottle Label
RASPBERRY GUAVA ANTIBACTERIAL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
WATERCRESS (UNII: K5877MW0LE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65903-360-016 in 1 BOX03/01/201402/01/2016
137 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E03/01/201402/01/2016
SEA MARINE ANTIBACTERIAL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-361
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
WATERCRESS (UNII: K5877MW0LE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65903-361-016 in 1 BOX03/01/201402/01/2016
137 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E03/01/201402/01/2016
Labeler - H2O Plus (807722947)

Revised: 7/2016
Document Id: fa7c5dea-03a0-44c9-a201-f3841a2a59f2
Set id: b5556c5b-3c2f-41c4-9587-b060728c8926
Version: 4
Effective Time: 20160715
 
H2O Plus