ZEP BLUE SKY FOAMING- triclosan liquid
Zep Inc.

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.

----------

Zep Blue Sky Foaming Hand Soap

Active ingredient

Triclosan 0.1%

Purpose

Antiseptic handwash

Uses

For hand washing to decrease bacteria on skin.

Warnings

For external use only.

Do not use in the eyes.

When using this product

if swallowed, seek medical attention.
if eye contact occurs, flush eyes with water and contact a physician.

Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.

Keep out of reach of children.

Directions

Wet hands with water
Place hands under dispenser
Apply foamed soap
Massage soap into hands and wrists, emphasizing back of hands, knuckles and cuticles
Rinse hands thoroughly and dry

Other information

Store at 20 to 25C (68 to 77°F).
Do not freeze.
Dispose in accordance with all applicable federal, state and local regulations.

Inactive ingredients

Water, TEA-Lauryl Sulfate, PEG-7 Glyceryl Cocoate, Tetrasodium Imidodisuccinate, Fragrance, Methylchloroisothiazolinone (and) Methylisothiazolinone, Glutaral, Blue 1

ZEP BLUE SKY FOAMING
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66949-769
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.01 g in 10 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLUTARAL (UNII: T3C89M417N)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66949-769-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2008	01/01/2020
2	NDC:66949-769-24	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2008	01/01/2020
3	NDC:66949-769-50	75680 mL in 1 DRUM; Type 0: Not a Combination Product	07/14/2008	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/14/2008	01/01/2020

Labeler - Zep Inc. (030471374)

Name	Address	ID/FEI	Business Operations
Establishment
Zep Inc.		030471374	manufacture(66949-769)

Revised: 9/2017

Document Id: 5a073197-6cc8-e89b-e053-2a91aa0a313f

Set id: cf8a14e2-a6a3-4ce5-b217-807e106d651c

Version: 7

Effective Time: 20170925

Zep Inc.

Zep Blue Sky Foaming Hand Soap

﻿Active ingredient

Purpose

﻿Uses

﻿Warnings

﻿Directions