ANTIBACTERIAL HAND SANITIZER SUNFLOWER AND CITRUS- ethyl alcohol gel

ANTIBACTERIAL HAND SANITIZER by

Drug Labeling and Warnings

ANTIBACTERIAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ETHYL ALCOHOL 62 PERCENT

PURPOSE

ANTISEPTIC

USES

TO HELP REDUCE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS OR LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

QUESTIONS OR COMMENTS

1-866-695-3030

INACTIVE INGREDIENTS

WATER, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, GLYCERIN, FRAGRANCE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CAPRYLIC/CAPRIC TRIGLYCERIDE, IRON OXIDES (CI 77491, CI 77492, CI 77891),MICA (CI 77019), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140),YELLOW 6 (CI 15985).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER  SUNFLOWER AND CITRUS
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-270
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-270-09	259 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/15/2011

Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture