Drug Labeling and Warnings

Drug Details

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SUNDROPS 67- chloroxylenol soap 
Sunburst Chemicals, Inc.

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.

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Active Ingredient

Chloroxylenol 0.75% w/w

Purpose

Skin Antimicrobial

Use

reduces amount of bacteria on hands

Warnings

For external use only.  Do not use in eyes.

Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

Not for use on children under six months of age.

For institutional and professional use only.

Directions

  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.

Inactive Ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1

Distributed Exclusively By:
Sunburst Chemicals
Minneapolis, MN  55420
www.sunburstchemicals.com

8 x 1000 mL Case Label

SUNDROPS 67 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63621-353
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorGREEN (green, dispensed as white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63621-353-658 in 1 BOX05/08/2008
11000 mL in 1 BAG; Type 0: Not a Combination Product
2NDC: 63621-353-806 in 1 BOX02/14/2008
2500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/14/2008
Labeler - Sunburst Chemicals, Inc. (006159339)

Revised: 10/2018
 
Sunburst Chemicals, Inc.


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