ORGANIC DIAPER RASH CREAM- zinc oxide cream
ALTEYA ORGANICS OOD

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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Organic Diaper Rash Cream

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. 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 (Beeswax)*, Garcinia Indica (Kokum) seed Butter*, Cetyl Alcohol, Euphorbia Cerifera (Candelilla Wax) Cera, Copernicia Cerifera (Carnauba Wax) Cera*, Cymbopogon Martini (Palmarosa) Oil*, Calendula Officinalis (Marigold) Flower Extract*, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Lavandula Angustifolia (Lavender) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Rosa Damascena (Rose) Flower Oil*, Tocopherol (Vitamin E), Geraniol**, Linalool**, Citronellol**, Limonene**, Farnesol**, Citral** .

* Certified Organic Ingredients ** Naturally occurring in 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.

Soothe, Treat and Prevent

Non-nano Zinc Oxide

Pediatrician Tested
Suitable for Sensitive Skin

CERTIFIED ORGANIC

www.NATRUE.ORG

Our Certified Organic Diaper Rash Cream is soothing treatment suitable for sensitive skin. 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

Not Tested on Animals

C/PE/ALU

NSF contains organic Ingredients

Packaging

untitled

ORGANIC DIAPER RASH CREAM
zinc oxide cream

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

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

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
YELLOW WAX (UNII: 2ZA36H0S2V)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
CETYL ALCOHOL (UNII: 936JST6JCN)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PALMAROSA OIL (UNII: 0J3G3O53ST)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)
TOCOPHEROL (UNII: R0ZB2556P8)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FARNESOL (UNII: EB41QIU6JL)
CITRAL (UNII: T7EU0O9VPP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71330-201-90	90 mL in 1 TUBE; Type 0: Not a Combination Product	09/16/2017	04/30/2021
2	NDC:71330-201-40	40 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/16/2017	05/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/16/2017	04/30/2021

Labeler - ALTEYA ORGANICS OOD (503572407)

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

Revised: 4/2021

Document Id: 063c0911-31c4-429c-bcd5-ecd93ce6faed

Set id: fe358645-3f54-439e-85a8-383d1f444b3e

Version: 4

Effective Time: 20210413

ALTEYA ORGANICS OOD