DIAPER RASH CREAM- zinc oxide lotion

Diaper Rash Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Zinc Oxide 14%

Warnings

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.

Warnings

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

Purpose

Skin Protectant

Warnings

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

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Helianthus Annuus (Sunflower) Seed Oil, Laminaria Ochroleuca Extract, Polyglyceryl-2 Dipolyhydroxystearate, Ricinus Communis (Castor) Seed Oil

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash

Helps seal out wellness

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

Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers may be prolonged.

Other information

Store at room tempreature and protect this product from direct sunlight.

Directions

Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers maybe be prolonged.

PRINCIPAL DISPLAY PANEL

EllaOla Diaper Cream Tube 88mL NDC: 82057-579-01

EllaOla Diaper Cream Carton NDC: 82057-579-02

INGREDIENTS AND APPEARANCE

DIAPER RASH CREAM 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82057-579
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 88 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82057-579-02	1 in 1 CARTON	09/30/2021
1	NDC: 82057-579-01	88 mL 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	09/30/2021

Labeler - EllaOla Brands Inc. (118147901)

Registrant - EllaOla Brands Inc. (118147901)