GIANT EAGLE PECAN PUMPKIN PIE 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%

Purpose

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), Propylene Glycol, Isopropyl Alcohol, Carbomer, Aminomethyl Propanol, Benzophenone-4, Glycerin, Fragrance (Parfum), Mannitol, Cellulose, Hydroxyethylcellulose, Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 (CI 42090), Red 40 (CI 16035), Yellow 5 (CI 19140).

Label Copy

Image of the label

GIANT EAGLE PECAN PUMPKIN PIE HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-015
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
SULISOBENZONE (UNII: 1W6L629B4K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-015-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/17/2018
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(63148-015)

Revised: 6/2018
Document Id: 14e3a90b-4b59-4cbc-a1a8-2841672ae8c7
Set id: e4c9a66e-9f37-4b79-8b50-42736afc2897
Version: 1
Effective Time: 20180620
 
Apollo Health and Beauty Care Inc.