DIAPER RASH CREAM 2.5OZ- zinc oxide cream

Diaper Rash Cream 2.5oz by

Drug Labeling and Warnings

Diaper Rash Cream 2.5oz by is a Otc medication manufactured, distributed, or labeled by Rejoice International Corp., China Ningbo Shangge Cosmetics Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 40%

Purpose

Skin protectant

Use

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

Stop use and ask a doctor if

Stop use and ask a doctor if

• condition worsen
• symptoms last more than 7 days or clear up and occur again within a few days

When using this product

When using this product do not get into eyes.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• change wet and soilded diapers promtly
• cleanse the diaper area
• allow to dry
• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged.

Other information

• store at 68º-77ºF(20º to 25ºC)
• do not use if tube seal under cap is broken or missing

Inactive ingredients

Petrolatum

Mineral Oil

Lanolin

Isopropyl Myristate

Beeswax

Tocopheryl Acetate

Cod Liver Oil

Aloe Barbadensis Leaf Juice

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIAPER RASH CREAM 2.5OZ 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.4 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
COD LIVER OIL (UNII: BBL281NWFG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-151-01	1 in 1 BOX	12/04/2023
1		71 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/04/2023

Labeler - Rejoice International Corp. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetics Technology Corp.		529287434	manufacture(57337-151)