ASTONEA- zinc oxide ointment 
ASTONEA LABS PRIVATE 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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ASTONEA Zinc oxide 20%

Active Ingredient

Zinc Oxide 20% w/w

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When using this product

■ do not get into eyes

■ do not use over large areas of the body

Stop use and ask a doctor if

■ the condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days ■ if you are allergic to any of these ingredients

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

Directions

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Other Information

■ store at 59-86F (15-30C)

Inactive Ingredients

cetostearyl alcohol, cetomacrogol 1000, lanolin, light liquid paraffin, white soft parrafin

Package Label

Principal Display and Drug Fact Panel

ASTONEA 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-304-0328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
2NDC:77338-304-0456.6 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
3NDC:77338-304-05425 g in 1 JAR; Type 0: Not a Combination Product05/23/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/23/2013
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 8/2022
Document Id: e68b3524-ed6f-55ec-e053-2995a90ab29c
Set id: e68b34ea-0cb3-574f-e053-2995a90ad828
Version: 1
Effective Time: 20220818
 
ASTONEA LABS PRIVATE LIMITED