BLUESEA INSTANT HAND SANITIZER- alcohol solution 
BLUE SEA AEROSOL & DAILY CARE CO., LTD

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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Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Use anywhere without water

Warnings

For external use only -hands

Flammable. Keep away from heat and flame

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

Discontinue if skin becomes irritated and ask a doctor

Keep out of reach of children. In case of accidental ingest, seek professional assistance or contact a Poison Control Center right away.

Directions

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, glycerin, carbomer, triethanolamine, Aloe

image description

BLUESEA INSTANT HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72119-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE (UNII: V5VD430YW9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72119-003-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
2NDC:72119-003-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
3NDC:72119-003-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
4NDC:72119-003-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
5NDC:72119-003-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - BLUE SEA AEROSOL & DAILY CARE CO., LTD (544373091)
Establishment
NameAddressID/FEIBusiness Operations
BLUE SEA AEROSOL & DAILY CARE CO., LTD544373091manufacture(72119-003)

Revised: 6/2020
Document Id: a798e083-a2a4-3cb7-e053-2995a90ac4c5
Set id: e6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd
Version: 1
Effective Time: 20200608
 
BLUE SEA AEROSOL & DAILY CARE CO., LTD