SPL v2
SPL
SPL Set ID bfea2a7d-e77b-b415-e053-2995a90af4c8
Route
TOPICAL
Published
Effective Date 2021-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (55 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-04-14

Description

calcium carbonate


Medication Information

Warnings and Precautions

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

Indications and Usage

■ apply proper amount to the skin

Dosage and Administration

for external use only

Description

calcium carbonate

Section 50565-1

• Keep Out of Reach of Children.

Section 51727-6

Carboxymethyl cellulose sodium salt, guargum, water

Section 51945-4

Section 55105-1

40% reduction in radon

TVOC reduction

Reduction of formaldehyde

Toluene reduction

More than 99% antibacterial

More than 80% of deodorization

Moisture absorption/moisture proof

No heavy metal detection

Firefighting: Semi-incombustible

Radiation of 90.2% of far-infrared rays

Section 55106-9

calcium carbonate


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)

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

Section 50565-1 (50565-1)

• Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Carboxymethyl cellulose sodium salt, guargum, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

40% reduction in radon

TVOC reduction

Reduction of formaldehyde

Toluene reduction

More than 99% antibacterial

More than 80% of deodorization

Moisture absorption/moisture proof

No heavy metal detection

Firefighting: Semi-incombustible

Radiation of 90.2% of far-infrared rays

Section 55106-9 (55106-9)

calcium carbonate


Advanced Ingredient Data


Raw Label Data

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