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.

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Earth Baby Diaper Rash Cream

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

EARTH BABY DIAPER RASH CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62588-904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
JOJOBA OIL (UNII: 724GKU717M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
CANOLA OIL (UNII: 331KBJ17RK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62588-904-021 in 1 BOX02/01/201912/31/2022
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/201912/31/2024
Labeler - Earth Baby, Inc (079298651)

Revised: 3/2021
Document Id: be1b787a-76af-f7a9-e053-2a95a90a0204
Set id: 42c5cf9a-0a35-5681-e054-00144ff8d46c
Version: 4
Effective Time: 20210322
 
Earth Baby, Inc