ANGEL OF MINE DIAPER RASH- zinc oxide ointment 
Bicooya Cosmetics Limited

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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Diaper Rash

Drug Facts

Active ingredient

Zinc Oxide 16%

Purposes

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Prevents chafed skin due to diaper rash
  • Helps seal out wetness

Warnings

For external use only.

When using this product

  • avoid contact wih eyes
  • this product contains chemicals, including lead, known to the State of California to case birth defects or othr reproductive harm 

Stop use and ask a doctor if

  • Condition worsens
  • or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Change wet or soiled diapers promptly
  • Clean the diaper area and allow to dry
  • Apply iubtnebt liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Inactive ingredients

boric acid, castor ol, fragrance, microcrystalline wax, mineral oil, paraffin, petrolatum

PRINCIPAL DISPLAY PANEL

Angel of mine™
diaper rash Ointment 

  • Soothes the rash
  • Helps heal
  • Wipes of easily 

Net Wt. 2 oz. (56g)

Principal Display Panel
ANGEL OF MINE DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58180-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE160 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CASTOR OIL (UNII: D5340Y2I9G)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58180-104-011 in 1 CARTON11/18/201404/08/2020
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/18/201404/08/2020
Labeler - Bicooya Cosmetics Limited (421310774)
Registrant - Bicooya Cosmetics Limited (421310774)
Establishment
NameAddressID/FEIBusiness Operations
Bicooya Cosmetics Limited421310774manufacture(58180-104)

Revised: 4/2020
Document Id: 3e4c3f67-65f7-4efc-b858-719b92f93f18
Set id: 60d7ca46-1a3f-42eb-a87f-b2848e56404f
Version: 10
Effective Time: 20200408
 
Bicooya Cosmetics Limited