INSTANT HAND SANITIZER- alcohol gel 
PUJIANG SHIJIALI COSMETICS 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 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

To reduce 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, propylene glycol, glycerin, carbomer, triethanolamine, fragrance

image description

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75236-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75236-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
2NDC:75236-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
3NDC:75236-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
4NDC:75236-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
5NDC:75236-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
Labeler - PUJIANG SHIJIALI COSMETICS CO., LTD. (529748603)
Establishment
NameAddressID/FEIBusiness Operations
PUJIANG SHIJIALI COSMETICS CO., LTD.529748603manufacture(75236-001)

Revised: 4/2020
Document Id: a44cd218-e4c6-a648-e053-2995a90afbab
Set id: bd88a162-d024-4451-bce4-f1b521d580d0
Version: 1
Effective Time: 20200427
 
PUJIANG SHIJIALI COSMETICS CO., LTD.