SUNDROPS 67- chloroxylenol soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)

Available from:

Sunburst Chemicals, Inc.

INN (International Name):

Chloroxylenol

Composition:

Chloroxylenol 0.75 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Antimicrobial reduces amount of bacteria on hands

Authorization status:

OTC monograph not final

Summary of Product characteristics

SUNDROPS 67- CHLOROXYLENOL SOAP
SUNBURST CHEMICALS, INC.
----------
SUNDROPS 67
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
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PRODUCT CHARACTERISTICS
COLOR
green (green, dispensed as white foam)
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
Sunburst Chemicals, Inc.
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:63621-
353-65
8 in 1 BOX
05/08/2008
06/30/2024
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 Drug
505G(a)(3)
02/14/2008
06/30/2024
LABELER -
Sunburst Chemicals, Inc. (006159339)
Revised: 11/2023