PROMISE ORGANICS DIAPER CREAM- diaper cream cream
Autumn Harp Incorporated

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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Promise Organics Diaper Cream

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. 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

• 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

Label image

PROMISE ORGANICS DIAPER CREAM
diaper cream cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51514-0353-1	93 g in 1 TUBE; Type 0: Not a Combination Product	03/22/2017	03/22/2017

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

Labeler - Autumn Harp Incorporated (064187883)

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

Revised: 7/2020

Document Id: aaa49d2b-5624-6884-e053-2995a90a4b13

Set id: 3d9385d0-6ef8-3d37-e054-00144ff88e88

Version: 2

Effective Time: 20200717

Autumn Harp Incorporated