Label: BEA-SILKY- alcohol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50254-365-01, 50254-365-03, 50254-365-05, 50254-365-06, view more50254-365-07, 50254-365-08, 50254-365-09, 50254-365-10, 50254-365-11, 50254-365-12, 50254-365-13, 50254-365-14, 50254-365-15, 50254-365-17, 50254-365-24, 50254-365-27, 50254-365-28, 50254-365-55 - Packager: Beaver Research 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 January 1, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-When Using Section
- Drug Facts Box OTC-Stop Use Section
- Drug Facts Box OTC-Keep Out of Reach of Children Section
- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
- Bea-Silky 6365 4oz
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INGREDIENTS AND APPEARANCE
BEA-SILKY
alcohol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50254-365 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER 1342 (UNII: 809Y72KV36) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) METHYLPARABEN (UNII: A2I8C7HI9T) DIISOPROPYLAMINE (UNII: BR9JLI40NO) CETEARYL ISONONANOATE (UNII: P5O01U99NI) CETEARETH-12 (UNII: 7V4MR24V5P) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL PALMITATE (UNII: 5ZA2S6B08X) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50254-365-06 1 in 1 BOX 1 800 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:50254-365-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:50254-365-24 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:50254-365-01 1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 5 NDC:50254-365-03 350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 6 NDC:50254-365-05 540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 7 NDC:50254-365-07 700 mL in 1 BAG; Type 0: Not a Combination Product 8 NDC:50254-365-09 2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 9 NDC:50254-365-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10 NDC:50254-365-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11 NDC:50254-365-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 12 NDC:50254-365-13 800 mL in 1 BAG; Type 0: Not a Combination Product 13 NDC:50254-365-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 14 NDC:50254-365-15 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 15 NDC:50254-365-28 149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 16 NDC:50254-365-27 800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 17 NDC:50254-365-55 208200 mL in 1 DRUM; Type 0: Not a Combination Product 18 NDC:50254-365-08 1 in 1 BOX 18 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2015 Labeler - Beaver Research Company (044960466) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(50254-365)