EARTH BABY HAND SANITIZER GEL- ethyl alcohol gel

Earth Baby Hand Sanitizer Gel by

Drug Labeling and Warnings

Earth Baby Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Earth Baby, Inc, V Manufacturing & Logistics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 62% v/v

PURPOSE

Purpose

Antiseptic

WARNINGS

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

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses to help reduce bacteria on the skin

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTH BABY HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62588-912
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62588-912-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020	02/01/2024
2	NDC: 62588-912-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020	02/01/2024
3	NDC: 62588-912-03	976 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2020	02/01/2024

Labeler - Earth Baby, Inc (079298651)

Registrant - V Manufacturing & Logistics, Inc. (079081508)