OTC Medication Information: GENERATIONS ANTIMICROBIAL

GENERATIONS ANTIMICROBIAL- chloroxylenol soap
Cole Papers

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.

Active ingredient

Chloroxylenol 0.3% w/w

Purpose

Antimicrobial

Keep out of reach of children

If swallowed, get medical attention or contact a poison control center immediately.

Uses

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

Warnings

For external use only

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Directions

 wet hands  apply small amount of product and work into a lather  rinse well and dry hands completely

Inactive ingredients:

Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Linear alcohol ethoxylate, Propylene glycol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Isopropyl myristate, Citric acid, FD&C Red #40, FD&C Red #33.

PRINCIPAL DISPLAY PANEL — 3785 mL Bottle Label
GENERATIONS
The Power of Experience Since 1918
Antimicrobial Lotion Soap Keep out of reach of children. CAUTION: See back panel for additional precautions. NET CONTENTS: 1 U.S. GALLON (3.78 LITERS)

image description
(click image for full-size original)

GENERATIONS ANTIMICROBIAL
chloroxylenol soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69554-524
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 3 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER
C9-11 PARETH-6
SODIUM LAURETH SULFATE
PROPYLENE GLYCOL
ISOPROPYL MYRISTATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
COCAMIDOPROPYL BETAINE
DMDM HYDANTOIN
PEG-120 METHYL GLUCOSE DIOLEATE
EDETATE SODIUM
CITRIC ACID MONOHYDRATE
SODIUM CHLORIDE
Product Characteristics
Color pink Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69554-524-28 3785 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/26/2015
Labeler — Cole Papers (006221444)

Revised: 01/2015 Cole Papers

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.