DYNAREX ZINC OXIDE- zinc oxide ointment ointment 
Dynarex Corporation

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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1190 Zinc Oxide Ointment NDC 67777-119-00
1191 Zinc Oxide Ointment​ NDC 67777-119-10
1192 Zinc Oxide Ointment​ NDC 67777-119-20

Active Ingredient

Zinc Oxide 25%

Purpose

Skin Protectant

Uses

Warnings

For External Use Only

When using this product

  • Avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other Information

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Light Liquid Paraffin, White Soft Paraffin

1190 Label

1190 BX MASTER1190 Label

1191 Label

1191 BX MASTER1191 Label

1192 Label

1192 IN MASTER1192 Label

DYNAREX ZINC OXIDE 
zinc oxide ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-119-0272 in 1 CASE03/27/2018
1NDC:67777-119-011 in 1 BOX
1NDC:67777-119-0028.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:67777-119-1272 in 1 CASE03/27/2018
2NDC:67777-119-111 in 1 BOX
2NDC:67777-119-1056.7 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:67777-119-2112 in 1 CASE03/27/2018
3NDC:67777-119-20425 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/27/2018
Labeler - Dynarex Corporation (008124539)

Revised: 11/2022
Document Id: ee2777e6-235a-30bd-e053-2a95a90afae4
Set id: 686729af-f96e-a860-e053-2a91aa0af575
Version: 6
Effective Time: 20221123
 
Dynarex Corporation