CAREONE COUNTRY APPLE- ethyl alcohol liquid 
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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Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

Warnings

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 and lasts.

Keep out of reach of children.

  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Mannitol, Cellulose, Hydroxypropyl Methylcellulose, Iron Oxides (CI 77491), Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

Label Copy

Image of the label

CAREONE  COUNTRY APPLE
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-410
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)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-410-08259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2017
2NDC:41520-410-0359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/16/2017
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(41520-410)

Revised: 5/2017
Document Id: b88957ae-1522-4a82-b8ce-c7bfb3f223c5
Set id: 68ba65c6-4ba7-44fe-a443-6ec4bec77414
Version: 1
Effective Time: 20170517
 
American Sales Company