Label: PREMIER PURE PROTECTION- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73945-004-01, 73945-004-02, 73945-004-03, 73945-004-04, view more73945-004-05, 73945-004-06, 73945-004-07, 73945-004-08, 73945-004-09, 73945-004-10, 73945-004-11, 73945-004-12 - Packager: RPP PRODUCTS, 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 May 5, 2020
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- Active ingredient
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
PREMIER PURE PROTECTION
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73945-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MONOETHANOLAMINE (UNII: 5KV86114PT) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73945-004-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 2 NDC:73945-004-02 88.72 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 3 NDC:73945-004-03 118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 4 NDC:73945-004-04 236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 5 NDC:73945-004-05 295.74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 6 NDC:73945-004-06 354.88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 7 NDC:73945-004-07 443.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 8 NDC:73945-004-08 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 9 NDC:73945-004-09 1890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 10 NDC:73945-004-10 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 11 NDC:73945-004-11 2800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 12 NDC:73945-004-12 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 04/10/2020 Labeler - RPP PRODUCTS, INC. (623623852) Establishment Name Address ID/FEI Business Operations RPP PRODUCTS, INC. 623623852 manufacture(73945-004)
