Label: PROTOCOXIL- benzyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71416-001-00, 71416-001-01 - Packager: Bio Ekuiliber LLC
- 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 November 27, 2020
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INGREDIENTS AND APPEARANCE
PROTOCOXIL
benzyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71416-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) MARITIME PINE (UNII: 50JZ5Z98QY) WHITE PEPPER OIL (UNII: 2AM83DL9FV) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71416-001-00 47 g in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2017 10/07/2019 2 NDC:71416-001-01 45 g in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/09/2017 Labeler - Bio Ekuiliber LLC (080648711)