EARTH BABY DIAPER RASH CREAM- zinc oxide cream

Earth Baby Diaper Rash Cream by

Drug Labeling and Warnings

Earth Baby Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Earth Baby, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Zinc Oxide 40%

PURPOSE

Skin Protectant

WARNINGS

Warnings
For external use only.

WHEN USING

When using this product Do not get into eyes

STOP USE

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

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

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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.

INDICATIONS & USAGE

Helps protect against diaper rash and irritation.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CARYODENDRON ORINOCENSE WHOLE (UNII: J2T2D81BHU)
CUCURBITA PEPO WHOLE (UNII: 48V44WX64I)
GLYCERIN (UNII: PDC6A3C0OX)
LAVANDULA X INTERMEDIA WHOLE (UNII: 9Q3NSN290F)
LONICERA CAPRIFOLIUM WHOLE (UNII: 4F67A99YTF)
OAT KERNEL OIL (UNII: 3UVP41R77R)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
CANOLA OIL (UNII: 331KBJ17RK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62588-904-02	1 in 1 BOX	02/01/2019	12/31/2022
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2019	12/31/2022

Labeler - Earth Baby, Inc (079298651)