Label: FRESH CUCUMBER MELON BODYCOLOGY- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51345-052-01 - Packager: Advanced Beauty Systems, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 25, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient purpose
Ethyl Alcohol 75% Antiseptic
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.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI77007)
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
FRESH CUCUMBER MELON BODYCOLOGY
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51345-052 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) GELATIN (UNII: 2G86QN327L) ALOE VERA LEAF (UNII: ZY81Z83H0X) 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:51345-052-01 1 in 1 BLISTER PACK 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 04/07/2011 Labeler - Advanced Beauty Systems, Inc. (129986613) Registrant - Advanced Beauty Systems, Inc. (129986613) Establishment Name Address ID/FEI Business Operations Giles Chemical, a division of Premier Magnesia, LLC 003162435 manufacture
