ORGANIC DIAPER RASH CREAM- zinc oxide cream

Organic Diaper Rash Cream by

Drug Labeling and Warnings

Organic Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by ALTEYA ORGANICS OOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Non-nano Zinc Oxide 17%

Purpose

Skin Protectant

Use:

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash
• Helps seal out wetness

Warnings:

For external use only

• If condition worsens or does not improve within 7 days, consult a physician.

• ​​​​​When using this product avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

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

Directions:

• Change wet or soiled diapers promptly. Clean the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged.

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil*, Prunus Armeniaca (Apricot) Kernel Oil*, Cera Alba (Bees) Wax*, Copernicia Cerifera (Carnauba) Wax*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Calendula Officinalis (Flower) Extract*, Hippophae Rhamnoides (Seabuckthorn) Extract*, Lavandula Angustifolia (Lavender) Oil*, Rosa Damascena (Rose) Flower Oil*, Tocopherol (Vitamin E), Eugenol**, Geraniol**, Citronellol**, Linalool**.

* certified organic ingredients; ** naturally occurring in pure essential oils.

Other information:

• Store at temperatures between 20-25°C/ 68-77°F. Keep away from excessive heat and direct sun. Higher or lower temperatures may cause the product to separate or thicken.

•  May stain some fabrics.

SPL UNCLASSIFIED SECTION

Soothe, Treat and Prevent

Non-nano Zinc Oxide

• Pediatrician Tested
• Suitable for Sensitive Skin

Our Certified Organic Diaper Rash Cream is soothing treatment suitable for most sensitive skins. Clinically tested and pediatrician approved,

it forms a protective barrier to help heal and soothe discomfort caused by diaper rash.

Not Tested on Animals

Manufactured by Alteya Organics LLC,

Yagoda 6167, Made in Bulgaria. www.AlteyaOrganics.com

Packaging

INGREDIENTS AND APPEARANCE

ORGANIC DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71330-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	17 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71330-201-90	90 mL in 1 TUBE; Type 0: Not a Combination Product	09/16/2017
2	NDC: 71330-201-40	40 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/16/2017	05/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/16/2017

Labeler - ALTEYA ORGANICS OOD (503572407)

Establishment
Name	Address	ID/FEI	Business Operations
ALTEYA ORGANICS OOD		503572407	manufacture(71330-201)