Earth Baby Diaper Rash Cream

Earth Baby Diaper Rash Cream
SPL v5
SPL
SPL Set ID 42c5cf9a-0a35-5681-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2019-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (40 g)
Inactive Ingredients
Aloe Carthamus Tinctorius (safflower) Oleosomes Caryodendron Orinocense Whole Cucurbita Pepo Whole Glycerin Lavandula X Intermedia Whole Lonicera Caprifolium Whole Oat Kernel Oil Hyaluronate Sodium Lonicera Japonica Flower Silicon Dioxide Jojoba Oil .alpha.-tocopherol Acetate Water Canola Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01

Description

Active Ingredient Zinc Oxide 40%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Helps protect against diaper rash and irritation.

Dosage and Administration

Directions

Change diaper promptly.

Clean diaper area, allow to dry

Apply a generous amount of creamwith each diaper change and before bedtime.

Description

Active Ingredient Zinc Oxide 40%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a 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 within a few days.

Section 50567-7

When using this product Do not get into eyes

Section 51727-6

Inactive ingredients:

Avena Sativa (Oat) Kernel Protein, Aloe Barbadensis Leaf Juice*, Aqua/Water, Beeswax, Canola Oil, Carthamus Tinctorius (Safflower) Oleosomes*, Caryodendron Orinocense (Kahai) Seed Oil, Cucurbita Pepo (Pumpkin) Extract, Glycerin, Lavandula Intermedia (Lavender) Flower/Leaf/Stem Extract*, Locinera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Parfum/Natural Fragrance, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch.

Section 51945-4

Section 55105-1



Skin Protectant

Section 55106-9

Active Ingredient

Zinc Oxide 40%

Section 60561-8

Other information

Store at 20° - 25°C (68° to 77°F)


Structured Label Content

Indications and Usage (34067-9)

Helps protect against diaper rash and irritation.

Dosage and Administration (34068-7)

Directions

Change diaper promptly.

Clean diaper area, allow to dry

Apply a generous amount of creamwith each diaper change and before bedtime.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a 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 within a few days.

Section 50567-7 (50567-7)

When using this product Do not get into eyes

Section 51727-6 (51727-6)

Inactive ingredients:

Avena Sativa (Oat) Kernel Protein, Aloe Barbadensis Leaf Juice*, Aqua/Water, Beeswax, Canola Oil, Carthamus Tinctorius (Safflower) Oleosomes*, Caryodendron Orinocense (Kahai) Seed Oil, Cucurbita Pepo (Pumpkin) Extract, Glycerin, Lavandula Intermedia (Lavender) Flower/Leaf/Stem Extract*, Locinera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Parfum/Natural Fragrance, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 40%

Section 60561-8 (60561-8)

Other information

Store at 20° - 25°C (68° to 77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)