ANTIMICROBIALSOAP by Suzhou Longlifu Health Food Co.,Ltd. 71333-102

ANTIMICROBIALSOAP by

Drug Labeling and Warnings

ANTIMICROBIALSOAP by is a Otc medication manufactured, distributed, or labeled by Suzhou Longlifu Health Food Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIMICROBIALSOAP- chloroxylenol gel 
Suzhou Longlifu Health Food Co.,Ltd.

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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71333-102

Active ingredients

Chloroxylenol 0.75% w/w

Antiseptic

Uses：

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

Warnings:

For external use only.

When using this product

• do not use in or near the eyes.

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

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

Directions:

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

Other information：

• store at room temperature.
• for healthcare professional use only.

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 .

ANTIMICROBIALSOAP 
chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71333-102
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)
COCONUT ACID (UNII: 40U37V505D)
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: 71333-102-01	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/03/2021	08/31/2022

Labeler - Suzhou Longlifu Health Food Co.,Ltd. (530536671)

Registrant - Suzhou Longlifu Health Food Co.,Ltd. (530536671)

Establishment
Name	Address	ID/FEI	Business Operations
Suzhou Longlifu Health Food Co.,Ltd.		530536671	manufacture(71333-102)

Revised: 10/2022

Document Id: ea1dc638-b3fe-930e-e053-2995a90acbca

34390-5

Set id: daba17b3-b4f6-47b5-a348-162014ef30f8

Version: 4

Effective Time: 20221003