ADVANCED HAND SANITIZER- alcohol gel 
Pro's Choice Beauty Care, Inc.

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

Active ingredients: Ethyl Alcohol 62%

INACTIVE INGREDIENT

Inactive ingredients:

Water/Aqua/Eau, Glycerin, Carbomer, 1,2-Hexanediol, Apium Graveolens (Celery) Extract, Daucus Carota Sativa (Carrot) Root Extract, Foeniculum Vulgare (Fennel) Seed Extract, Brassica Oleracea Acephala Leaf Extract, Coriandrum Sativum (Coriander) Extract, Lactuca Scariola Sativa (Lettuce) Leaf Extract, Spinacia Oleracea (Spinach) Leaf Extract

PURPOSE

Purpose: Antiseptic

WARNINGS

Warnings:
For external use only : hands
Flammable, keep away from fire or 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
Stop use and ask a doctor if ■irritation and redness develop ■ condition persists for more than 72 hours
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses:
■ for handwashing to decrease the bacteria on the skin
■ recommended for repeated use

Directions

Directions:

■ Apply enough amount into palm and spread on both hands. rub into skin until dry.

■ for children under 6, use only under adult supervision

■ not recommended for infants

Other information

Other information


■ do not store above 105℉

■ may discolor some fabrics

■ harmful to wood finishes and plastics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

ADVANCED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75585-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL310 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
CELERY (UNII: 44IDY6DTKX)  
CARROT (UNII: L56Z1JK48B)  
FENNEL SEED (UNII: G3QC02NIE6)  
KALE (UNII: 0Y3L4J38H1)  
CORIANDER (UNII: 1OV56052IK)  
LETTUCE (UNII: 5PO6NN3RRJ)  
SPINACH (UNII: 6WO75C6WVB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75585-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - Pro's Choice Beauty Care, Inc. (015441970)
Registrant - Pro's Choice Beauty Care, Inc. (015441970)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(75585-010)

Revised: 4/2020
Document Id: 375e07cd-adfd-4eab-a5f8-65a39205e9df
Set id: bb788b8e-48e1-4fc6-ae59-b17e848ee7b5
Version: 1
Effective Time: 20200422
 
Pro's Choice Beauty Care, Inc.