Angel of mine Diaper Rash by Bicooya Cosmetics Limited Diaper Rash

Angel of mine Diaper Rash by

Drug Labeling and Warnings

Angel of mine Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Bicooya Cosmetics Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

ANGEL OF MINE DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58180-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CASTOR OIL (UNII: D5340Y2I9G)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58180-104-01	1 in 1 CARTON	11/18/2014	04/08/2020
1		56 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 final	part347	11/18/2014	04/08/2020

Labeler - Bicooya Cosmetics Limited (421310774)

Registrant - Bicooya Cosmetics Limited (421310774)

Establishment
Name	Address	ID/FEI	Business Operations
Bicooya Cosmetics Limited		421310774	manufacture(58180-104)

Revised: 4/2020

Document Id: 3e4c3f67-65f7-4efc-b858-719b92f93f18

34390-5

Set id: 60d7ca46-1a3f-42eb-a87f-b2848e56404f

Version: 10

Effective Time: 20200408

 

Bicooya Cosmetics Limited