LITTLE ONES BABY FRESH SANITIZER- ethyl alcohol liquid

Little Ones by

Drug Labeling and Warnings

Little Ones by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to help decrease bacteria on the skin.

Warnings

For external use only.

• Flammable
• Keep away from source of heat or fire.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directons

• put enough product in your palm to cover hands and rub hands together until dry
• children under 6 years should be supervised when using this product.

Other information

• store at a temperature below 110°F (43°C)
• may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Red 33 (CI 17200).

Questions or comments?

1-800-842-7886

Label Copy

INGREDIENTS AND APPEARANCE

LITTLE ONES  BABY FRESH SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
glycerin (UNII: PDC6A3C0OX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-413-03	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2017
2	NDC: 49738-413-07	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2017
3	NDC: 49738-413-33	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/22/2017

Labeler - Kmart Corporation (008965873)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(49738-413)