ANGEL OF MINE DIAPER RASH- zinc oxide ointment
Wenzhou Senos Cosmetics Technology Co., Ltd.

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:58638-002
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58638-002-01	56 g in 1 TUBE; Type 0: Not a Combination Product	05/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/22/2017

Labeler - Wenzhou Senos Cosmetics Technology Co., Ltd. (420430722)

Registrant - Wenzhou Senos Cosmetics Technology Co., Ltd. (420430722)

Name	Address	ID/FEI	Business Operations
Establishment
Wenzhou Senos Cosmetics Technology Co., Ltd.		420430722	manufacture(58638-002)