PROMISE ORGANICS DIAPER CREAM- diaper cream cream

Promise Organics Diaper Cream by

Drug Labeling and Warnings

Promise Organics Diaper Cream by is a Otc medication manufactured, distributed, or labeled by Autumn Harp Incorporated, Autumn Harp Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 14.00%

Purpose

Skin protectant

Uses

helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps protect skin from wetness

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

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, cleanse the diaper area and allow to dry

DOSAGE & ADMINISTRATION

apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Beeswax*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Butyrospermum Parkii (Shea Butter)*, Colloidal Oatmeal*, Tocopherol (Vitamin E), Azadirachta indica (Neem) Kernel oil Organic*, Citric Acid.

* Certified Organic Ingredients

Other Information

protect this product from excessive heat and direct sun

Principle Display Panel

image

INGREDIENTS AND APPEARANCE

PROMISE ORGANICS DIAPER CREAM 
diaper cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
OATMEAL (UNII: 8PI54V663Y)
AZADIRACHTA INDICA BARK (UNII: G580B439YI)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0353-1	93 g in 1 TUBE; Type 0: Not a Combination Product	03/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/22/2017

Labeler - Autumn Harp Incorporated (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp Inc.		064187883	manufacture(51514-0353)