SPL v1
SPL
SPL Set ID 203375a3-50db-7c1e-e063-6394a90a4039
Route
TOPICAL
Published
Effective Date 2024-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Chlorohydrate (78 mg)
Inactive Ingredients
Polyoxyl 40 Hydrogenated Castor Oil Methylparaben Diazolidinyl Urea Hypromelloses Edetate Disodium Glycerin Triethylamine Water

Identifiers & Packaging

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

Description

Antiperspirant

Purpose

Antiperspirant


Medication Information

Purpose

Antiperspirant

Description

Antiperspirant

Use

Reduces underarm perspiration.

Section 50565-1

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

Section 50570-1

on broken skin.

Warnings

For external use only

Directions

Apply to underarms only.

Bottle Label

ZONSEN TM

PERSONAL CARE

Clear Roll-On

Antiperspirant

FRESH SCENT

1.5 FL. OZ. (44ml)

Active Ingredient

Aluminum Chlorohydrate 7.8%

Discontinue Use If

■irritation and redness develop

■ If condition persists for more than 72 hours consult a doctor.

Inactive Ingredient

Water, PEG-40 Hydrogenated Castor Oil, Diazolidinyl Urea, Hydroxyproply Methyl Cellulose, Glycerin, Methylparaben, Disodium EDTA,Triethylamine, Fragrance

Ask A Doctor Before Use

if you have kidney disease.

Dosage & Administration

Use daily for best results.


Structured Label Content

Use

Reduces underarm perspiration.

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

on broken skin.

Purpose (PURPOSE)

Antiperspirant

Warnings

For external use only

Directions

Apply to underarms only.

Bottle Label (BOTTLE LABEL)

ZONSEN TM

PERSONAL CARE

Clear Roll-On

Antiperspirant

FRESH SCENT

1.5 FL. OZ. (44ml)

Active Ingredient (ACTIVE INGREDIENT)

Aluminum Chlorohydrate 7.8%

Discontinue Use If (DISCONTINUE USE IF)

■irritation and redness develop

■ If condition persists for more than 72 hours consult a doctor.

Inactive Ingredient (INACTIVE INGREDIENT)

Water, PEG-40 Hydrogenated Castor Oil, Diazolidinyl Urea, Hydroxyproply Methyl Cellulose, Glycerin, Methylparaben, Disodium EDTA,Triethylamine, Fragrance

Ask A Doctor Before Use (ASK A DOCTOR BEFORE USE)

if you have kidney disease.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Use daily for best results.


Advanced Ingredient Data


Raw Label Data

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