CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E - ethyl alcohol gel
AMERICAN SALES COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

ETHYL ALCOHOL 62 PERCENT

PURPOSE

ANTIMICROBIAL

USES

TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.

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 RASH 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

PLACE ENOUGH PRODUCT IN YOUR PALM TO COVER YOUR HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

INACTIVE INGREDIENTS

WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER,

FRAGRANCE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-223
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 934 (UNII: Z135WT9208)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-223-02	59 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/08/2011

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

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