Natural Diaper Rash

Active Ingredients:

Zinc Oxide 12%

Skin Protection

Uses:

Helps treat and prevent diaper rash.
Protects chafed skin and minor irritation associated with diaper rash.
Helps seal out wetness.

WARNINGS:

For external use only.

When using this product,

avoid contact with eyes.

Stop use and ask a doctor if:

Conditions worsen.
Symptoms last more then seven days.

Keep out of reach of children.

if swallowed, get medical help immediately or contact poison control center right away.

DIRECTION:

Change wet and soiled diapers promptly.
Cleans the diaper area and allow to dry.
Apply cream liberally, as often as necessary, with each diaper change, especially at bed time or before any prolonged exposure to wet diapers.

Other infomation:

Store at 15° -30° C [59°-86°)

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Chamomilla Recutita (Chamomile) Oil, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavendar) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

Label2

NATURAL DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70668-827
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
COCONUT OIL (UNII: Q9L0O73W7L)
CUCUMBER (UNII: YY7C30VXJT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LAVENDER OIL (UNII: ZBP1YXW0H8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70668-827-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	05/10/2017	07/24/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	05/10/2017	07/24/2017

Labeler - Products On The Go, LLC (060619487)

Revised: 10/2023

Document Id: 074334af-c26d-4126-e063-6394a90ae4c4

Set id: 4fa7948f-5089-3aa6-e054-00144ff8d46c

Version: 2

Effective Time: 20231009

Products On The Go, LLC