PREFACE EARTH BABY HAND SANITIZER GEL- organic ethyl alcohol gel 
Earth Baby, 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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Preface Earth Baby Hand Sanitizer Gel+

Active Ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

For external use only. Flammable. Keep away from fire or flame.

When using this product avoid contact with eyes. If eye contact occurs, rinse with water.

Stop use and ask a doctor if skin irritation or redness develops.

Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Uses to help reduce bacteria on the skin

Directions apply enough gel to wet hands and rub together until dry. Use 1 to 3 times daily.

Other information do not store above 104°F (40°C).

Inactive ingredients Aloe Barbadensis Leaf Juice*, Carthamus Tinctorius (Safflower) Oleosomes*, Glycerin, Hydroxyethylcellulose, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Alcohol, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Parfum (Fragrance Natural), Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate.

*Certified Organic Ingredient

EBPHSG2PEBHSG2DF

PREFACE EARTH BABY HAND SANITIZER GEL 
organic ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62588-910
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
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ROSEMARY (UNII: IJ67X351P9)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62588-910-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/202002/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/202002/01/2024
Labeler - Earth Baby, Inc (079298651)
Registrant - V Manufacturing & Logistics, Inc. (079081508)

Revised: 3/2021
Document Id: be1b9b72-f44e-97f3-e053-2995a90ac8ba
Set id: a153e81b-aaa9-ff02-e053-2995a90a52c6
Version: 3
Effective Time: 20210322
 
Earth Baby, Inc