EAU D AMOUR ANTIPERSPIRANT DEODORANT ROLL ON FOR WOMEN- aluminum chlorohydrate cream
Zermat Internacional S.A. de C.V.

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.

----------

eau d'amour Antiperspirant Deodorant Roll-On for Women

DRUG FACTS

Active Ingredient:

Aluminum Chlorohydrate 20%

Purpose

Antiperspirant

Use

For odor protection. Reduces underarm perspiration.

Warnings

For external use only

Do not use

on broken skin

Stop use if

if rash or irritation occurs

Ask a doctor before use

if you have a kidney disease

Keep out of reach of children.

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

Directions:

Shake well before use. Apply to underarms only. Close tight after use.

Inactive Ingredients:

Water, Fragrance, Steareth-2, Steareth-20, PPG-15 Stearyl Ether, Helianthus Annuus Seed Oil, Water /Glycerin / Lecithin / Sorbitol / Xanthan Gum / Sodium Ascorbyl Phosphate / Kojic Acid, Talc, Salvia Officinalis Extract, Hamamelis Virginiana Extract, Polyaminopropyl Biguanide, Citrus Grandis Seed Extract.

Package Labeling:

Label

EAU D AMOUR ANTIPERSPIRANT DEODORANT ROLL ON FOR WOMEN
aluminum chlorohydrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15828-211
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
KOJIC ACID (UNII: 6K23F1TT52)
TALC (UNII: 7SEV7J4R1U)
SAGE (UNII: 065C5D077J)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
CITRUS MAXIMA SEED (UNII: 083X55C543)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15828-211-01	1 in 1 CASE	07/20/2016	02/28/2018
1		65 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	07/20/2016	02/28/2018

Labeler - Zermat Internacional S.A. de C.V. (812820712)

Revised: 12/2017

Document Id: 6156acdb-897f-072c-e053-2991aa0a4c87

Set id: a3ffb764-f404-4c15-950e-72ef824e7568

Version: 3

Effective Time: 20171227

Zermat Internacional S.A. de C.V.