Label: ANTISEPTIC- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51718-3112-1 - Packager: Telestar
- 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 March 19, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- unsnap entire canister cap and thread towelette through pre-cut slot
- pull towelette out of cap slot at an angle to dispense
- wet hands and wrists thoroughly with wipe for 15 seconds and allow to air dry
- dispose of used towelette properly
- always reseal after use
- children under 6 years of age should be supervised when using this product
- Inactive ingredients
- Principal Display Panel - Canister Label
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51718-3112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 665 mL in 1 L Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51718-3112-1 0.52 L in 1 CANISTER; 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 03/19/2015 Labeler - Telestar (963337303) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(51718-3112)