Drug Facts

Active ingredient

Chloroxylenol 0.2%

Purpose

Antiseptic

Uses:

For handwashing to decrease bacteria on the skin.

Warnings:

Avoid contact with eyes. In case of contact, flush thoroughly with water. For external use only.

Stop use:

if irritation or redness develops.

If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

Wet hands and forearms. Apply 5 ml (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

Other information:

Store in a cool place away from direct sunlight.

Inactive ingredients:

Water, sodium lauryl sulfate, Cocamide DEA, Cocamidopropyl Betaine, Glycerin, Citric Acid, Sodium chloride, Disodium EDTA, fragrance, Methylchloroisothiazolinone and Methylisothiazolinone, D&C Red NO.33, FD&C Blue NO.1

Package Labeling:

Label2 Label3

TENDERLAVEN HAND
chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69771-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69771-006-10	10 in 1 CASE	12/01/2020
1		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	01/01/2020

Labeler - Geri-Gentle Corporation (080367686)

TenderLaven Hand Soap