SPL v1
SPL
SPL Set ID dd15c7ac-091f-4a99-a0e6-473184148b61
Route
TOPICAL
Published
Effective Date 2010-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2 g) Zinc Oxide (0.8 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-21

Description

Active Ingredients: Stearalkorium Hectorite, Bentonite, Titanium Dioxide, Zinc Oxide, Talc


Medication Information

Warnings and Precautions
Warning:

1. Discontinue if the following symptom appears and consult with dermatologist for the continuous problem of use

    a) Discontinue use if redness, rash, irritation or tingling appears

    b) Discontinue if the above symptom appears by a direct sunlight on the applied part

2. Avoid the part for a cut, eczema or dermatitis

Description

Active Ingredients: Stearalkorium Hectorite, Bentonite, Titanium Dioxide, Zinc Oxide, Talc

Section 44425-7
Storage and Handling:

- To keep the freshness, please close the lid after the use

- Do not store this product in a place of high or low temperature

- Do not expose it to the direct sunlight

Section 50565-1
Keep this and all drugs out of reach of children

Section 50567-7
Direction of use:

Apply evenly onto clean and moisturized skin after the cleansing and massage all over the skin with circular movement for 1-2 minutes.  Then leave them about 2-3 minutes.  Rinse with room temperature water (do not use with soap).  Use two or three times a week.

Section 51727-6
Inactive Ingredients:

Water, Triticum Vulgare (Wheat) Starch, Butylene Glycol, Magnesium Aluminum Silicate, PEG-32, Alcohol, Tocopheryl Acetate, Methylparaben, Cabomer, Propylparaben, Disodium EDTA, Egg Oil, Aloe Barbadensis Leaf, Algae Extract, Royal Jelly Extract, Fragrance

Section 51945-4
Section 55106-9
Active Ingredients:

Stearalkorium Hectorite, Bentonite, Titanium Dioxide, Zinc Oxide, Talc


Structured Label Content

Warnings and Precautions (34071-1)
Warning:

1. Discontinue if the following symptom appears and consult with dermatologist for the continuous problem of use

    a) Discontinue use if redness, rash, irritation or tingling appears

    b) Discontinue if the above symptom appears by a direct sunlight on the applied part

2. Avoid the part for a cut, eczema or dermatitis

Section 44425-7 (44425-7)
Storage and Handling:

- To keep the freshness, please close the lid after the use

- Do not store this product in a place of high or low temperature

- Do not expose it to the direct sunlight

Section 50565-1 (50565-1)
Keep this and all drugs out of reach of children

Section 50567-7 (50567-7)
Direction of use:

Apply evenly onto clean and moisturized skin after the cleansing and massage all over the skin with circular movement for 1-2 minutes.  Then leave them about 2-3 minutes.  Rinse with room temperature water (do not use with soap).  Use two or three times a week.

Section 51727-6 (51727-6)
Inactive Ingredients:

Water, Triticum Vulgare (Wheat) Starch, Butylene Glycol, Magnesium Aluminum Silicate, PEG-32, Alcohol, Tocopheryl Acetate, Methylparaben, Cabomer, Propylparaben, Disodium EDTA, Egg Oil, Aloe Barbadensis Leaf, Algae Extract, Royal Jelly Extract, Fragrance

Section 51945-4 (51945-4)
Section 55106-9 (55106-9)
Active Ingredients:

Stearalkorium Hectorite, Bentonite, Titanium Dioxide, Zinc Oxide, Talc


Advanced Ingredient Data


Raw Label Data

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