SPL v2
SPL
SPL Set ID fd527b10-5a50-4b07-8b5d-fac66768bc0d
Route
TOPICAL
Published
Effective Date 2019-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Zirconium Tetrachlorohydrex Gly (20 g)
Inactive Ingredients
Cyclomethicone 5 Stearyl Alcohol Hydrogenated Castor Oil Hydrogenated Polydecene (550 Mw) Glyceryl Monostearate Peg-100 Stearate Aluminum Starch Octenylsuccinate Aloe Vera Leaf Witch Hazel .alpha.-tocopherol Acetate Activated Charcoal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-09-12

Description

Active ingredient Aluminum Zirconium Tetrachlorohydrex GLY 20%


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Do not use on broken skin.

Stop use if rash or irritation occurs.

Ask a doctor before use if you have kidney disease.

Indications and Usage

Uses:  Reduces underarm perspiration. Provides long-lasting defense against odor.

Dosage and Administration

Directions:  Apply to underarms only. 

Description

Active ingredient Aluminum Zirconium Tetrachlorohydrex GLY 20%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help

or contact a poison control center right away. 

Section 51727-6

Inactive Ingredients: Cyclopentasiloxane, Stearyl Alcohol, Hydrogenated Castor Oil, 

Hydrogenated Polydecene, Glyceryl Stearate, PEG-100 Stearate, Fragrance,

Aluminum Starch Octenylsuccinate, Aloe Barbadensis Leaf Extract, Witch Hazel Distillate,

Tocopheryl Acetate (Vitamin E), Charcoal Powder

Section 51945-4

Section 55105-1

Purpose

Antiperspirant

Section 55106-9

Active ingredient

Aluminum Zirconium Tetrachlorohydrex GLY 20%


Structured Label Content

Indications and Usage (34067-9)

Uses:  Reduces underarm perspiration. Provides long-lasting defense against odor.

Dosage and Administration (34068-7)

Directions:  Apply to underarms only. 

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Do not use on broken skin.

Stop use if rash or irritation occurs.

Ask a doctor before use if you have kidney disease.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help

or contact a poison control center right away. 

Section 51727-6 (51727-6)

Inactive Ingredients: Cyclopentasiloxane, Stearyl Alcohol, Hydrogenated Castor Oil, 

Hydrogenated Polydecene, Glyceryl Stearate, PEG-100 Stearate, Fragrance,

Aluminum Starch Octenylsuccinate, Aloe Barbadensis Leaf Extract, Witch Hazel Distillate,

Tocopheryl Acetate (Vitamin E), Charcoal Powder

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiperspirant

Section 55106-9 (55106-9)

Active ingredient

Aluminum Zirconium Tetrachlorohydrex GLY 20%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)