Label: ENCHANTED FOREST HAND SANITIZER BODYCOLOGY- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51345-051-01 - 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 July 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
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007)
May Contain: FD and C No.4 (CI 14700), FD and C Yellow No. 5 (CI 19140) FD and C Blue No. 1 (CI 42090), D and C Red No. 33 (CI 17200)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ENCHANTED FOREST HAND SANITIZER BODYCOLOGY
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51345-051 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) 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:51345-051-01 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 Landy International 545291775 manufacture(51345-051)