SPL v1
SPL
SPL Set ID 20332dd6-43a8-4cc4-e063-6294a90a2220
Route
TOPICAL
Published
Effective Date 2024-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Aluminum Chlorohydrate 4.5%

Purpose

Antiperspirant


Medication Information

Purpose

Antiperspirant

Description

Aluminum Chlorohydrate 4.5%

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, Methyl paraben, Propylparaben, Glycerin, Hydroxyethyl cellulose, Disodium EDTA, Tween-60, Triethylamine, Diazolidinyl Urea

Ask Doctor Before Use

if you have kidney disease.

Dosage & Administration

Use daily for best results.

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.

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

Aluminum Chlorohydrate 4.5%

Inactive Ingredient

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

Ask Doctor Before Use (Ask Doctor before use)

if you have kidney disease.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Use daily for best results.

Keep Out of Reach of Children (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)