Label: CARE ONE VANILLA BEAN- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-500-02 - Packager: AMERICAN SALES COMPANY
- Category: HUMAN OTC DRUG LABEL
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 October 28, 2013
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- ACTIVE INGREDIENT
- USES
- WARNINGS
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), YELLOW 5 (CI 19140), RED 33 (CI 17200), EXT. VIOLET 2 (CI 60730)
- LABEL COPY
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INGREDIENTS AND APPEARANCE
CARE ONE VANILLA BEAN
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-500 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MANNITOL (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) HYPROMELLOSES (UNII: 3NXW29V3WO) SULISOBENZONE (UNII: 1W6L629B4K) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) D&C VIOLET NO. 2 (UNII: 350KA7O6HK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-500-02 59 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/27/2013 Labeler - AMERICAN SALES COMPANY (809183973) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41520-500)