SPL v2
SPL
SPL Set ID 2032bd55-a9f8-651e-e063-6394a90ab110
Route
TOPICAL
Published
Effective Date 2024-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Chlorohydrate (45 mg)
Inactive Ingredients
Mineral Oil Dimethicone Butylated Hydroxytoluene Edetate Disodium Water Stearic Acid Propylparaben Glycerin Triethylamine Polysorbate 60 Sorbitan Monostearate Cetostearyl Alcohol Glyceryl Monostearate Diazolidinyl Urea Methylparaben Hydroxyethyl Cellulose, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-21

Description

For external use only

Purpose

Antiperspirant


Medication Information

Purpose

Antiperspirant

Dosage and Administration

Use daily for best results.

Description

For external use only

Use

Reduces underarm perspiration.

Stop Use

if rash or irritation occurs.

Warnings

For external use only

Do Not Use

on broken skin.

Directions

Apply to underarms only

Package Label

Active Ingredient

Aluminum Chlorohydrate 4.5%

Inactive Ingredient

Water, Stearic acid, Mineral Oil, Sorbitan Monostearate, Cetylstearyl Alcohol, Dimethicone, Glyceryl stearate, Butylated Hydroxytoluene, Methylparaben, Propylparaben, Glycerin, Hydroxyethyl cellulose,Disodium EDTA, Tween-60, Triethylamine, Diazolidinyl Urea, Fragrance

Ask Doctor Before Use

if you have kidney disease.

Keep Out of Reach of Children

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


Structured Label Content

Use (USE)

Reduces underarm perspiration.

Dosage and Administration (34068-7)

Use daily for best results.

Purpose (PURPOSE)

Antiperspirant

Stop Use (Stop use)

if rash or irritation occurs.

Warnings

For external use only

Do Not Use (DO NOT USE)

on broken skin.

Directions

Apply to underarms only

Package Label (Package label)

Active Ingredient (ACTIVE INGREDIENT)

Aluminum Chlorohydrate 4.5%

Inactive Ingredient

Water, Stearic acid, Mineral Oil, Sorbitan Monostearate, Cetylstearyl Alcohol, Dimethicone, Glyceryl stearate, Butylated Hydroxytoluene, Methylparaben, Propylparaben, Glycerin, Hydroxyethyl cellulose,Disodium EDTA, Tween-60, Triethylamine, Diazolidinyl Urea, Fragrance

Ask Doctor Before Use

if you have kidney disease.

Keep Out of Reach of Children

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)