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Name:Alloyantiperspirant And Deodorant
Manufacturer:Melaleuca, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Alloy Antiperspirant & Deodorant Content of Label

ALLOY ANTIPERSPIRANT AND DEODORANT - aluminum zirconium tetrachlorohydrex gly stick 
Melaleuca, 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.

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Alloy Antiperspirant & Deodorant Content of Label

Active ingredient
Aluminum zirconium tetrachlorohydrex-gly 17.8%

Purpose
Antiperspirant

Use reduces underarm perspiration

Warnings
For external use only

Do not use on broken skin

Ask a doctor before use if you have kidney disease

Stop use and ask a doctor if rash or irritation occurs

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

Directions

  • turn dial to raise product
  • apply 2 - 3 passes to underarms only

Other information do not freeze or store above 115°F (46°C)

Inactive ingredients
Aloe barbadensis leaf juice, Camellia sinensis leaf extract, cyclopentasiloxane, fragrance, hydrogenated castor oil, PEG-8 distearate, PPG-14 butyl ether, sodium bicarbonate, stearyl alcohol, talc, tocopherol, Zea mays (corn) starch

image of label

image of trial label


ALLOY  ANTIPERSPIRANT AND DEODORANT
aluminum zirconium tetrachlorohydrex gly stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-151
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.39 g  in 64 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
GREEN TEA LEAF  
Cyclomethicone 5  
HYDROGENATED CASTOR OIL  
PEG-8 DISTEARATE  
PPG-14 BUTYL ETHER  
SODIUM BICARBONATE  
STEARYL ALCOHOL  
Talc  
ALPHA-TOCOPHEROL ACETATE  
STARCH, CORN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54473-151-02 64 g in 1 APPLICATOR None
2 NDC:54473-151-01 12 g in 1 APPLICATOR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part350 05/01/2007

Labeler - Melaleuca, Inc (139760102)
Establishment
Name Address ID/FEI Operations
Body Blue 2006 Incorporated 243094112 manufacture

Revised: 02/2011 Melaleuca, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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