Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6d83af00-acae-433b-8a5f-6d93df8ea82e
Route
TOPICAL
Published
Effective Date 2016-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1.92 g)
Inactive Ingredients
Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-02-04

Description

zinc oxide


Medication Information

Warnings and Precautions

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Indications and Usage

apply proper amount to the skin

Dosage and Administration

for external use only

Description

zinc oxide

Section 50565-1

keep out of reach of the children

Section 51727-6

titanium dioxide, water, etc

Section 51945-4

Section 55105-1

for skin protectant

Section 55106-9

zinc oxide


Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

titanium dioxide, water, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for skin protectant

Section 55106-9 (55106-9)

zinc oxide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)