AURORA ANTIBACTERIAL SANITIZER SWEET LYCHEE BERRY- ethyl alcohol liquid

AURORA by

Drug Labeling and Warnings

AURORA 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 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 6 YEARS OF AGE AND UNDER SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110°F (43°C)

INACTIVE INGREDIENTS

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), BENZOPHENONE-4, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, BLUE 1 (CI 42090), RED 33 (CI 17200)

QUESTIONS OR COMMENTS?

1-866-695-3030

LABEL COPY

INGREDIENTS AND APPEARANCE

AURORA  ANTIBACTERIAL SANITIZER SWEET LYCHEE BERRY
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-407
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)
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-407-02	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	01/12/2015

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(63148-407)