ASTONEA SKIN PROTECTANT- zinc oxide ointment 
ASTONEA LABS PRIVATE LIMITED

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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 DrugM01611/21/2019
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-050)

Revised: 6/2024
Document Id: 1bbb3c29-f7ab-8b08-e063-6294a90a0129
Set id: e3c7a515-3e77-da85-e053-2995a90a3ee1
Version: 3
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED