ANTIMICROBIALSOAP- chloroxylenol gel

ANTIMICROBIALSOAP by

Drug Labeling and Warnings

ANTIMICROBIALSOAP by is a Otc medication manufactured, distributed, or labeled by NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Chloroxylenol 0.75% w/w

PURPOSE

Antiseptic

INDICATIONS & USAGE

Uses：

• for hand-washing to decrease microbes on the skin.
• ideal for daily repeated washing

WARNINGS

Warnings:

For external use only.

WHEN USING

When using this product

• do not use in or near eyes.

STOP USE

• discotinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

DOSAGE & ADMINISTRATION

Directions:

• wet hands
• apply product (palmful)
• wash hands vigorously
• rinse thoroughly

OTHER SAFETY INFORMATION

Other information:

• store at room temperature
• for healthcare professional use only

INACTIVE INGREDIENT

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No.8, FD&C Blue No.1, FD&C Yellow No.5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIMICROBIALSOAP 
chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47993-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCO-BETAINE (UNII: 03DH2IZ3FY)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
D&C GREEN NO. 8 (UNII: I2W85YOX9L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MONOETHANOLAMINE (UNII: 5KV86114PT)
OLEIC ACID (UNII: 2UMI9U37CP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM SULFATE (UNII: 0YPR65R21J)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47993-325-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2021
2	NDC: 47993-325-02	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2021
3	NDC: 47993-325-03	800 mL in 1 BAG; Type 0: Not a Combination Product	06/15/2021
4	NDC: 47993-325-04	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2021

Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)

Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)