LEMON DROP GENTLE ANTISEPTIC- chloroxylenol liquid

Lemon Drop Gentle Antiseptic by

Drug Labeling and Warnings

Lemon Drop Gentle Antiseptic by is a Otc medication manufactured, distributed, or labeled by Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Choroxylenol 0.3%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses:

For hand washing to decrease bacteria on the skin.

WARNINGS

Warnings:

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

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

DOSAGE & ADMINISTRATION

Directions:

Apply to hands, add small amount of water and lather.

Work until soil is emulsified, rinse and wipe dry.

STORAGE AND HANDLING

Other Information:

Store at 20 to 25 C (68 to 77 F)

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Propylene Glycol, Sodium Chloride, Fragrance and Glycerin.

PRINCIPAL DISPLAY PANEL

PK

Lemon Drop

gentle lotion soap

antiseptic

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

Made in USA

Stock # 245

3.78 Liters (1 Gallon)

INGREDIENTS AND APPEARANCE

LEMON DROP GENTLE ANTISEPTIC 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1006-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2014
2	NDC: 11429-1006-2	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2014
3	NDC: 11429-1006-4	2125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2014
4	NDC: 11429-1006-5	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1006)