Budpak Diaper Rash Cream

Budpak Diaper Rash Cream
SPL v1
SPL
SPL Set ID 15c427f3-09a8-4514-b95a-cf966c574f3a
Route
TOPICAL
Published
Effective Date 2014-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (13 g)
Inactive Ingredients
Water Mineral Oil Petrolatum Yellow Wax Dimethicone Sorbitan Sesquioleate Microcrystalline Wax Peg-30 Dipolyhydroxystearate Magnesium Sulfate Phenoxyethanol Methylparaben Potassium Hydroxide Propylparaben .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-14

Description

Active Ingredient Zinc Oxide 13%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash. Helps seal out wetness

Dosage and Administration

Directions

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Description

Active Ingredient Zinc Oxide 13%

Section 42229-5

Other Information

Store at 20°to 25°C (68° to 77°F).

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again in few days.

Section 50567-7

When using this product do not get into eyes

Section 51727-6

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Fragrance, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Zinc Oxide 13%


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash. Helps seal out wetness

Dosage and Administration (34068-7)

Directions

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other Information

Store at 20°to 25°C (68° to 77°F).

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again in few days.

Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Fragrance, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 13%


Advanced Ingredient Data


Raw Label Data

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