61010-8600-1, Saniwashantimicrobial Foming Hand

SPL v4

SPL

SPL Set ID bab4ca5f-01c6-4146-b18f-c22cbe0fe13b

Route

TOPICAL

Published

Effective Date 2016-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chloroxylenol (0.006 g)

Inactive Ingredients

Aloe Vera Leaf Sodium Laureth-3 Sulfate Coco Diethanolamide Cocamidopropyl Betaine Dmdm Hydantoin Propylene Glycol Water Edetate Sodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-03-13

Description

Chloroxylenol (PCMX)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Chloroxylenol (PCMX)

Uses

For hand washing to decrease bacteria on the skin.
Recommended for repeated use

Section 50565-1

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask doctor ifirritation or redness develop and persists for more than 72 hours.

Warnings

For external use only.

Directions

Wet hands and forearms. Apply 5 millimeters (teaspoonful) or palmful to hand and forearm. Scrub thoroughly for 30 seconds. Rince and repeat.

Active Ingredient

Chloroxylenol (PCMX)

Inactive Ingredients

aloe vera, calblend clear surfactant blend, DMDM hydantoin, fragrance, propylene glycol, purified/deionized water, tetrasodium EDTA, vitamin E acetate

Principal Display Panel

PRINCIPAL DISPLAY PANEL -18.6 fl. oz

NDC 61010-8600-1

Safetec

Saniwash

Antimicrobial Foaming Hand Soap

Effective against germs

Cleans dirty hands yet gentle on skin

Mild pleasant fragrance with Aloe

Manufactured by

Safetec

Safetec of America, Inc

Buffalo, NY 14215

1-800-456-7077 www.safetec.com Reorder No. 34456 Net Contents

18.6 fl. Oz (550 ml)

When Using This Product

supervise children under 6
do not use in eyes. If contact occurs, rinse thoroughly with water.

Structured Label Content

Uses

For hand washing to decrease bacteria on the skin.
Recommended for repeated use

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask doctor ifirritation or redness develop and persists for more than 72 hours.

Purpose

Antiseptic

Warnings

For external use only.

Directions

Wet hands and forearms. Apply 5 millimeters (teaspoonful) or palmful to hand and forearm. Scrub thoroughly for 30 seconds. Rince and repeat.

Active Ingredient

Chloroxylenol (PCMX)

Inactive Ingredients (Inactive ingredients)

aloe vera, calblend clear surfactant blend, DMDM hydantoin, fragrance, propylene glycol, purified/deionized water, tetrasodium EDTA, vitamin E acetate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PRINCIPAL DISPLAY PANEL -18.6 fl. oz

NDC 61010-8600-1

Safetec

Saniwash

Antimicrobial Foaming Hand Soap

Effective against germs

Cleans dirty hands yet gentle on skin

Mild pleasant fragrance with Aloe

Manufactured by

Safetec

Safetec of America, Inc

Buffalo, NY 14215

1-800-456-7077 www.safetec.com Reorder No. 34456 Net Contents

18.6 fl. Oz (550 ml)

When Using This Product (When using this product)

supervise children under 6
do not use in eyes. If contact occurs, rinse thoroughly with water.

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH-3 SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCO DIETHANOLAMIDE", "unii": "92005F972D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROXYLENOL", "unii": "0F32U78V2Q", "classCode": "ACTIB", "strengthNumerator": "0.006", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin. Recommended for repeated use", "50565-1": "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Wet hands and forearms. Apply 5 millimeters (teaspoonful) or palmful to hand and forearm. Scrub thoroughly for 30 seconds. Rince and repeat.", "Active Ingredient": "Chloroxylenol (PCMX)", "Inactive ingredients": "aloe vera, calblend clear surfactant blend, DMDM hydantoin, fragrance, propylene glycol, purified/deionized water, tetrasodium EDTA, vitamin E acetate", "PRINCIPAL DISPLAY PANEL": "PRINCIPAL DISPLAY PANEL -18.6 fl. oz NDC 61010-8600-1 Safetec Saniwash Antimicrobial Foaming Hand Soap Effective against germs Cleans dirty hands yet gentle on skin Mild pleasant fragrance with Aloe Manufactured by Safetec Safetec of America, Inc Buffalo, NY 14215 1-800-456-7077 www.safetec.com Reorder No. 34456 Net Contents 18.6 fl. Oz (550 ml)", "When using this product": "supervise children under 6 do not use in eyes. If contact occurs, rinse thoroughly with water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.070700 · Updated: 2026-03-14T23:02:30.868416