Label: BODYCOLOGY TOASTED VANILLA KIT- toasted vanilla kit
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Contains inactivated NDC Code(s)
NDC Code(s): 51345-057-01, 51345-058-01 - Packager: Advanced Beauty Systems, Inc.
- 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 August 20, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Drug Facts
Active ingredient Purpose
Ethyl Alcohol 75% Antiseptic
Uses To decrease bacteria on the skin.
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact aPoisonControlCenter immediately.
Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours.
Warnings
For external use only.
FLAMMABLE. Keep away from heat and flame.
When using this product
Avoid contact with eyes. If contact occurs, flush eyes with water.
Avoid contact with broken skin.
Directions
-Wet hands with product.
-Briskly rub hands together until dry.
-For children under 6, use only under adult supervision.
-Not recommended for infants.
Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007).
May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODYCOLOGY TOASTED VANILLA KIT
toasted vanilla kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51345-057 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51345-057-01 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 30 mL Part 2 1 BOTTLE 30 g Part 1 of 2 BODYCOLOGY TOASTED VANILLA SUGAR HAND SANITIZER
ethyl alcohol gelProduct Information Item Code (Source) NDC:51345-058 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 22.5 mL in 30 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) GELATIN (UNII: 2G86QN327L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) ULTRAMARINE BLUE (UNII: I39WR998BI) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51345-058-01 30 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/30/2012 Part 2 of 2 BODYCOLOGY NOURISHING BODY
body and hand (excluding shaving preparations)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR SOYBEAN OIL (UNII: 241ATL177A) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR GLYCERYL STEARATE SE (UNII: FCZ5MH785I) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR COCOA BUTTER (UNII: 512OYT1CRR) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR SULISOBENZONE (UNII: 1W6L629B4K) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR 2,4-DIAMINOPHENOXYETHANOL HYDROCHLORIDE (UNII: Z5Y843J6KQ) INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) INGR FD&C RED NO. 4 (UNII: X3W0AM1JLX) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/30/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/30/2012 Labeler - Advanced Beauty Systems, Inc. (129986613) Registrant - Advanced Beauty Systems, Inc. (129986613) Establishment Name Address ID/FEI Business Operations Landy International 545291775 manufacture(51345-057, 51345-058)
