Label: CAREONE ANTIBACTERIAL SANITIZER LIMONCELLO- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-411-03 - Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 26, 2017
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- Active ingredient
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
CAREONE ANTIBACTERIAL SANITIZER LIMONCELLO
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-411 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) CARBOMER 934 (UNII: Z135WT9208) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) MANNITOL (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) HYPROMELLOSES (UNII: 3NXW29V3WO) CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-411-03 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/25/2017 Labeler - American Sales Company (809183973) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(41520-411)