Label: BODYCOLOGY VANILLA CUPCAKE- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-992-01, 49035-992-02 - Packager: Wal-Mart Stores, 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 April 8, 2011
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 70% 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 and allow to dry without wiping. 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 (Aloe Vera leaf juice), Ultramarines (CI77007)
May contain: FD C Red No.4(CI 14700, Aka504), FD C Yellow No. 5 (CI 19140,Ki4), FD C Blue No.1 (CI 42090, Ao1), D C Red No 33(CI 17200,Aka227)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODYCOLOGY VANILLA CUPCAKE
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-992 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO) 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:49035-992-02 1 in 1 BOTTLE 1 NDC:49035-992-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/09/2011 Labeler - Wal-Mart Stores, Inc. (051957769)