Earth Baby Diaper Rash Cream: Package Insert and Label Information

EARTH BABY DIAPER RASH CREAM- zinc oxide cream
Earth Baby, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient
Zinc Oxide 40%


Skin Protectant

Warnings For external use only.

When using this product Do not get into eyes

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
Change diaper promptly.
Clean diaper area, allow to dry
Apply a generous amount of creamwith each diaper change and before bedtime.

Other information
Store at 20° — 25°C (68° to 77°F)

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.

Helps protect against diaper rash and irritation.

DRC
(click image for full-size original)

EARTH BABY DIAPER RASH CREAM
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62588-904
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 40 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62588-904-02 1 TUBE in 1 BOX contains a TUBE
1 50 g in 1 TUBE This package is contained within the BOX (62588-904-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/01/2019 12/31/2024
Labeler — Earth Baby, Inc (079298651)

Revised: 03/2021 Earth Baby, Inc

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