SUNDROPS 67- chloroxylenol soap

SunDrops 67 by

Drug Labeling and Warnings

SunDrops 67 by is a Otc medication manufactured, distributed, or labeled by Sunburst Chemicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNDROPS 67 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63621-353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q)	Chloroxylenol	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN (green, dispensed as white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63621-353-65	8 in 1 BOX	05/08/2008
1		1000 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 63621-353-80	6 in 1 BOX	02/14/2008	03/18/2020
2		500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/14/2008

Labeler - Sunburst Chemicals, Inc. (006159339)