DIAPER RASH CREAM 2.5OZ- zinc oxide cream 
Rejoice International Corp.

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DIAPER RASH CREAM 2.5OZ

Active ingredient

Zinc Oxide 40%

Purpose

Skin protectant

Use

Warnings

Warnings: For external use only.

When using this product

When using this product do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symtoms 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 right away.

Do not use

Do not use if tube seal under cap is broken or missing

Directions

Other information

Inactive ingredients

Petrolatum, Mineral Oil, Lanolin, Isopropyl Myristate, Beeswax, Tocopheryl Acetate, Cod Liver Oil, Aloe Barbadensis Leaf Juice

label

labl 1

label 2

DIAPER RASH CREAM 2.5OZ 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN (UNII: 7EV65EAW6H)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-165-011 in 1 BOX03/07/2024
171 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01603/07/2024
Labeler - Rejoice International Corp. (078741245)
Establishment
NameAddressID/FEIBusiness Operations
Astonea Labs Private Limited878533295manufacture(57337-165)

Revised: 3/2024
Document Id: 130da1aa-ffef-2aeb-e063-6394a90af92d
Set id: 130d94d8-ad98-d61f-e063-6294a90a76b0
Version: 1
Effective Time: 20240307
 
Rejoice International Corp.