OCEAN BREEZE  - alcohol gel 
Shanghai Weierya Daily Chemicals Factory

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

Inactive Ingredients

carbomer 940, Peg-12 dimethicone, propylene glycol,

tocopheryl acetate, triethanolamine, water

Active Ingredient

Ethyl Alcohol 68% v/v

Purpose

Antimicrobial

Warnings

For external use only

Keep out of reach of children

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

right away

Uses

hand sanitizer to help reduce bacteria on skin

Directions - Put a dime sized

drop onto hands and rub together briskly

until dry.

Do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Flammable. Keep away

from fire or flame

Other Information.

Store below 110 F (43C)

copy of label

OCEAN BREEZE  
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58194-007
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 68 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58194-007-01 29 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/01/2013
Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
Establishment
Name Address ID/FEI Business Operations
Shanghai Weierya Daily Chemicals Factory 420359333 manufacture(58194-007)

Revised: 11/2013
Document Id: 456455cf-7860-4163-8a98-33c655e863ac
Set id: f4a75cac-9528-4929-95f1-c8e570e3deff
Version: 1
Effective Time: 20131113
 
Shanghai Weierya Daily Chemicals Factory