CAREONE ANTIBACTERIAL HAND SANITIZER FESTIVAL OF LIGHTS- 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. 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

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OLD SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

INACTIVE INGREDIENT

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, POLYETHYLENE, TRIETHOXYCAPRYLYLSILANE, ISOPROPYL MYRISTATE, ULTRAMARINES (CI 77007), RED 33 (CI 17200), EXT. VIOLET 2 (CI 60730), BLUE 1 (CI 42090)

LABEL COPY

INGREDIENTS AND APPEARANCE

CAREONE  ANTIBACTERIAL HAND SANITIZER FESTIVAL OF LIGHTS
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-502
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ULTRAMARINE BLUE (UNII: I39WR998BI)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-502-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/14/2014

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(41520-502)