CAREONE ANTIBACTERIAL SANITIZER LIMONCELLO- ethyl alcohol liquid

CAREONE by

Drug Labeling and Warnings

CAREONE by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to 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 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.

Directions

• 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.

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Chromium Hydroxide Green (CI 77289), Blue 1 (CI 42090), Yellow 5 (CI 19140).

Label Copy

INGREDIENTS AND APPEARANCE

CAREONE  ANTIBACTERIAL SANITIZER LIMONCELLO
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-411
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)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-411-03	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/25/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/25/2017

Labeler - American Sales Company (809183973)

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

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(41520-411)