CURETECH SKIN PROTECTANT- zinc oxide ointment 
CURETECH SKINCARE

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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Curetech Gard

Drug Facts

Active ingredient

Zinc Oxide (1.8% w/w)

Purpose

Skin Prorectant

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), 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, Vitamin A Palmitate, Water.

Package Labeling:

Principal Display & Drug Fact Panel

CURETECH SKIN PROTECTANT 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73622-0500
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
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)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73622-0500-4113 g in 1 TUBE; Type 0: Not a Combination Product11/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/21/2019
Labeler - CURETECH SKINCARE (677682180)

Revised: 2/2020
Document Id: 9e3def8c-eafa-124d-e053-2995a90ad2f5
Set id: 9e3def80-b173-7422-e053-2a95a90ac0b8
Version: 1
Effective Time: 20200210
 
CURETECH SKINCARE