CLOROX FRAGANZIA ANTIBACTERIAL HAND- chloroxylenol soap
Skaffles Group Limited Liability Company

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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77720-010 Clorox Fraganzia antibacterial hand soap 0.3%CHLOROXYLENOL

Active Ingredient

Chloroxylenol 0.3%.

Purpose

Antibacterial

USE

For handwashing to decrease bacteria on the skin.

Warning

For external use only: hands only
When using this product avoid contact with the eyes.
If contact occurs, rinse eyes with water.
Stop use and ask a doctor if irritation or redness
develops- 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

Directions Apply onto wet hands, lather for at least
30 seconds and rinse thoroughly

Inactive ingredients

WATER,SODIUM LAURETH SULFATE,COCAMIDOPROPYL
BETAINE,GLYCERIN,COCAMIDE METHYL MEA,SODIUM
CHLORIDE,PARFUM,CITRIC ACID,DISODIUM EDTA,
METHYLCHLOROISOTHIAZOLINONE AND
METHYLISOTHIAZOLINONE.

CLOROX FRAGANZIA ANTIBACTERIAL HAND
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77720-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77720-010-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
2	NDC:77720-010-02	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
3	NDC:77720-010-03	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
4	NDC:77720-010-04	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
5	NDC:77720-010-05	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
6	NDC:77720-010-06	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
7	NDC:77720-010-07	651 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
8	NDC:77720-010-08	1006 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
9	NDC:77720-010-09	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020
10	NDC:77720-010-10	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/22/2020

Labeler - Skaffles Group Limited Liability Company (831115642)

Name	Address	ID/FEI	Business Operations
Establishment
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD.		544493972	manufacture(77720-010)