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.

Active Ingredient

Active Ingredient

Zinc Oxide 40%

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 60561-8

Other information

Store at 20° - 25°C (68° to 77°F)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active Ingredient

Zinc Oxide 40%

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.

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 60561-8 (60561-8)

Other information

Store at 20° - 25°C (68° to 77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)