Label: PREMIER PURE PROTECTION- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73945-006-01, 73945-006-02, 73945-006-03, 73945-006-04, view more73945-006-05, 73945-006-06 - 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 June 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Put enough product in your palm to cover your hand and rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using PREMIER PURE.
Other information
- Store below 110° F (43° C)
- May discolor certain fabrics or surfaces.
- This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
PREMIER PURE PROTECTION
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73945-006 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) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73945-006-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2020 2 NDC:73945-006-02 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2020 3 NDC:73945-006-03 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2020 4 NDC:73945-006-04 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2020 5 NDC:73945-006-05 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2020 6 NDC:73945-006-06 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/08/2020 Labeler - RPP PRODUCTS, INC. (623623852)