ASTONEA SKIN PROTECTANT- 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 skin protectant 1.8% ZNO

Drug Facts

Active ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Protectant

Uses:

Warnings:

For external use only

When using this product

  • Avoid contact with eyes
  • If eye contact occurs, flush with water

Stop use and ask a doctor if:

  • Condition worsens or does not improve within seven days

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away

Directions:

Other information:

Inactive ingredients:

Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), Ethylhexylglycerine, FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, stearic acid, Vitamin A Palmitate, Water.

Package Labeling:

Principal Display and Drug Fact Panel

ASTONEA SKIN PROTECTANT 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-050-04113 g in 1 TUBE; Type 0: Not a Combination Product08/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/21/2019
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-050)

Revised: 8/2022
Document Id: e5bd673b-72ee-2dae-e053-2a95a90a24e1
Set id: e3c7a515-3e77-da85-e053-2995a90a3ee1
Version: 2
Effective Time: 20220808
 
ASTONEA LABS PRIVATE LIMITED