Label: HAND GEL PROLIM INSTANT HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50414-100-01, 50414-100-02, 50414-100-03, 50414-100-04, view more50414-100-05, 50414-100-06, 50414-100-07, 50414-100-08, 50414-100-09 - Packager: Prolim Quimica Avancada Ltda.
- Category: HUMAN OTC DRUG LABEL
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 February 15, 2010
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- Active Ingredient
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- When using this product
- STOP USE
- Keep out of reach of children
- SPL UNCLASSIFIED SECTION
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- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
HAND GEL PROLIM INSTANT HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50414-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 0.7 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50414-100-01 60 mL in 1 BOTTLE, PLASTIC 2 NDC:50414-100-02 80 mL in 1 BOTTLE, PLASTIC 3 NDC:50414-100-03 100 mL in 1 BOTTLE, PLASTIC 4 NDC:50414-100-04 200 mL in 1 BOTTLE, PUMP 5 NDC:50414-100-05 500 mL in 1 BOTTLE, PUMP 6 NDC:50414-100-06 1000 mL in 1 BOTTLE, PUMP 7 NDC:50414-100-07 5000 mL in 1 BOTTLE, PLASTIC 8 NDC:50414-100-08 1 in 1 BOX 8 800 mL in 1 BAG 9 NDC:50414-100-09 1 in 1 BOX 9 1200 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 03/10/2010 Labeler - Prolim Quimica Avancada Ltda. (907224518) Establishment Name Address ID/FEI Business Operations Prolim Quimica Avancada Ltda. 907224518 manufacture