ALLCAREU DISPOSABLE HAND SANITIZER- alcohol solution 
JIANGSU AllCARE BIOTECH PHARMACEUTICAL 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 65% 

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, glycerin, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, triethanolamine, fragrance, PANTHENOL, LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT

image description

ALLCAREU DISPOSABLE HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78988-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
PANTHENOL (UNII: WV9CM0O67Z)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78988-001-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
2NDC:78988-001-02354 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
3NDC:78988-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/13/2020
Labeler - JIANGSU AllCARE BIOTECH PHARMACEUTICAL CO., LTD (554534691)
Establishment
NameAddressID/FEIBusiness Operations
JIANGSU AllCARE BIOTECH PHARMACEUTICAL CO., LTD554534691manufacture(78988-001)

Revised: 7/2020
Document Id: aa58eb89-2a2c-79ea-e053-2a95a90ae3ff
Set id: 4359be70-e8d4-4505-9dd1-829e2c24b648
Version: 1
Effective Time: 20200713
 
JIANGSU AllCARE BIOTECH PHARMACEUTICAL CO., LTD