Label: GELRITE- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-106-04, 61924-106-16, 61924-106-27, 61924-106-34 - Packager: DERMARITE INDUSTRIES, LLC
- 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 January 13, 2022
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- Active Ingredient
- Purpose
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- Other Information
- Inactive ingredients
- Questions?
- Keep out of reach of children
- GelRite Package Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
GELRITE
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER 940 (UNII: 4Q93RCW27E) DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H) BUTANOL (MIXED ISOMERS) (UNII: WB09NY83YA) 2,4,5-T-TROLAMINE (UNII: 9007L1DAXM) SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-106-04 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/25/2006 2 NDC:61924-106-16 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/25/2006 3 NDC:61924-106-27 800 mL in 1 BAG; Type 0: Not a Combination Product 04/25/2006 4 NDC:61924-106-34 1000 mL in 1 BAG; Type 0: Not a Combination Product 04/25/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/25/2006 Labeler - DERMARITE INDUSTRIES, LLC (883925562) Registrant - DERMARITE INDUSTRIES, LLC (883925562) Establishment Name Address ID/FEI Business Operations DERMARITE INDUSTRIES LLC 883925562 manufacture(61924-106)