SIMPLE HYGIENE ANTIBACTERIAL FOAM HAND- chloroxylenol soap

Simple Hygiene Antibacterial Foam Hand by

Drug Labeling and Warnings

Simple Hygiene Antibacterial Foam Hand by is a Otc medication manufactured, distributed, or labeled by Fuller Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Chloroxylenol 0.5%

Purpose

Antiseptic

Uses

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

Warnings

For external use only

Do not use 

in the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if

• irritatation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Pump a small amount of foam into palm of hand
• Rub thoroughly over all surfaces of both hands
• Rub hands together to produce a thick lather
• Rinse and repeat

Inactive Ingerdients

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Yellow No. 6, D&C Red No. 33, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Oletin Sulfonate, Water

Package Labeling:60933-106-01

Package Labeling:60933-106-02

Package Labeling:60933-106-03

INGREDIENTS AND APPEARANCE

SIMPLE HYGIENE ANTIBACTERIAL FOAM HAND 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60933-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60933-106-01	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2022
2	NDC: 60933-106-02	6 in 1 CASE	02/01/2022
2		1000 mL in 1 BAG; Type 0: Not a Combination Product
3	NDC: 60933-106-03	4 in 1 CASE	02/01/2022
3		3790 mL in 1 BOTTLE; 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)	02/01/2022

Labeler - Fuller Industries, LLC (078704329)

Establishment
Name	Address	ID/FEI	Business Operations
Fuller Industries, LLC		078704329	manufacture(60933-106)