GIANT EAGLE LEMON HAND SANITIZER- ethyl alcohol liquid 
Apollo Health and Beauty Care Inc.

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 65%

Purpos

Antiseptic

Uses

to help reduce bacteria on the skin.

Warnings

For external use only

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly 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. 1-800-222-1222.

Directions

Other information

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Yellow 5 (CI 19140), Yellow 10 (CI 47005).

Label Copy

Image of the label

GIANT EAGLE LEMON HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-509
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-509-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/10/2019
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-509)

Revised: 7/2019
Document Id: f9f77646-b5a4-468b-87a2-e34fd9d5ab48
Set id: b1112d76-0c1e-4fb4-8e02-2d6ae00ef583
Version: 1
Effective Time: 20190710
 
Apollo Health and Beauty Care Inc.