WASH FREE DISINFECTION- wash free disinfection gel 
Guangdong Bolicen Bio-Technology 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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Wash Free Disinfection Gel

Active Ingredient(s)

Alcohol75%v/v

Purpose

Antiseptic

Use

Hand sanitizing for Intact skin

Warnings

External use, keep out of reach of children, avoid eyes and ear.
Use with caution for who allergic to ethanol.
Keep away from light, sealed, moisture-proof, store in a cool, dry placee.
Flammable. Keep away from fire or flame.

Do not use

In children less than 2 months of ageOn open skin wounds

/

Stop ues and ask a doctor if
Pruritus, redness and swelling of hands, allergy, etc.

Children under 6 years of age when using this product to avoid swallowing.

Directions

Wet hands with proper amount of the product, and keep the liquid for 1 minute until the liquid covers the whole hand and dry.
Children under 6 years of age when using this product to avoid swallowing.

Other information

Do not store above 40 °C. May discolor some fabrics and surfaces
Store between15-30°C

Inactive ingredients

Water, Triethanolamine, Carbomer

Package Label - Principal Display Panel

60120300500

WASH FREE DISINFECTION 
wash free disinfection gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78293-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78293-005-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78293-005-02120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78293-005-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78293-005-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Guangdong Bolicen Bio-Technology Co., Ltd. (554525110)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Bolicen Bio-Technology Co., Ltd.554525110manufacture(78293-005)

Revised: 7/2020
Document Id: aa10d28a-673b-45c4-e053-2995a90a8ed2
Set id: a688fc02-b6a4-e807-e053-2a95a90a1302
Version: 2
Effective Time: 20200710
 
Guangdong Bolicen Bio-Technology Co., Ltd.