c5f2ec40-9706-621d-e053-2995a90a0eb0

SPL v1
SPL
SPL Set ID c5f2ec40-9706-621d-e053-2995a90a0eb0
Route
topical
Published
Effective Date 2021-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (12 g)
Inactive Ingredients
sunflower oil castor oil carnauba wax

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2021-09-30

Purpose

Skin Protectant

Description

Zinc Oxide 14%


Medication Information

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.

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash

Helps seal out wellness

Purpose

Skin Protectant

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.

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

Description

Zinc Oxide 14%

Section 51945-4

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

EllaOla Diaper Cream Carton NDC: 82057-579-02

Active Ingredient

Zinc Oxide 14%


Structured Label Content

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.

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash

Helps seal out wellness

Purpose

Skin Protectant

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 (Other information)

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

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

Section 51945-4 (51945-4)

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

EllaOla Diaper Cream Carton NDC: 82057-579-02

Active Ingredient

Zinc Oxide 14%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)