FDA.reportPublic FDA data

PRO-LINK ProFormance Foaming Antimicrobial SP

Manufacturer
Pro-Link, Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:32:23

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

Uses

Handwash to help decrease bacteria on the skin Recommended for repeated use

Warnings

Warnings

For external use only

Directions And Dosage

Directions

Wet hands Apply product and thoroughly cover hands with lather Rinse well and dry hands completely

Other Label Information

Inactive ingredients

Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

Label Images#

6f0ebb21-80e7-402d-8664-b480cf68a261
6f0ebb21-80e7-402d-8664-b480cf68a261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66908-083-42PRO-LINK ProFormance Foaming Antimicrobial SP1250 mL in 1 PACKAGELIQUID12503
66908-083-67PRO-LINK ProFormance Foaming Antimicrobial SP2000 mL in 1 PACKAGELIQUID20003

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66908-08366908-083-42, 66908-083-67

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMMONIUM XYLENESULFONATE4FZY6L6XCMIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LACTIC ACID33X04XA5ATIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
JOJOBA OIL724GKU717MIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CORN OIL8470G57WFMIACT
AMMONIUM SULFATESU46BAM238IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C RED NO. 4X3W0AM1JLXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CHLOROXYLENOL0F32U78V2QACTIB

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Handwash to help decrease bacteria on the skin Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands Apply product and thoroughly cover hands with lather Rinse well and dry hands completely

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

Source Document#

Source XML