CONFIELLE ANTIPERSPIRANT AND DEODORANT ROLL-ON ORIGINAL- aluminum chlorohydrate liquid

Confielle by

Drug Labeling and Warnings

Confielle by is a Otc medication manufactured, distributed, or labeled by Omega & Delta Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Aluminum Chlorohydrate 20%

Purpose

Antiperspirant

INDICATIONS & USAGE

Use: Reduces underarm wetness

WARNINGS

Warnings: For external use only

DO NOT USE

Do not use on broken skin

STOP USE

Stop use if rash or irritation occurs

ASK DOCTOR

Ask a doctor before use if you have kidney disease

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center.

DOSAGE & ADMINISTRATION

Directions:  Apply evenly to underarms only

INACTIVE INGREDIENT

Inactive Ingredients:  Water, PPG-15 Stearyl Ether, Steareth-2, Steareth-21, Fragrance, Disodium EDTA, BHT, Triclosan

SPL UNCLASSIFIED SECTION

Distributed by:

Omega & Delta Co., Inc.

Carolina, P.R. 00984

www.omegadeltaco.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONFIELLE  ANTIPERSPIRANT AND DEODORANT ROLL-ON ORIGINAL
aluminum chlorohydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51048-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRICLOSAN (UNII: 4NM5039Y5X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51048-301-25	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/08/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M019	05/08/2006

Labeler - Omega & Delta Co (090317793)

Establishment
Name	Address	ID/FEI	Business Operations
Omega & Delta Co		090317793	manufacture(51048-301)