ZINC-OXYDE PLUS- menthol, zinc oxide ointment 
First Aid Research Corp.

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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Zinc Oxide Plus

Drug Facts

Active ingredients

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Uses

A moisture barrier that prevents and helps heal skin irritation from: • urine • diarrhea • perspiration • fistula damage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching

Warnings

For external use only

• not for deep or puncture wounds 

• avoid contact with eyes

Stop use and ask a doctor

• if condition worsens or does not improve within 7 days.

Keep out of reach of children. In case of accidental ingestion contact a physician or poison control center immediately.

Directions

Inactive ingredients

butylated hydroxytoluene, calamine, cetyl esters, glycerin, glycerol monostearate, lanolin, PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol, white petrolatum

Questions?

call 516-783-0274

label

ZINC-OXYDE PLUS 
menthol, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.4 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION206 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LANOLIN (UNII: 7EV65EAW6H)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
THYMOL (UNII: 3J50XA376E)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75983-006-571 in 1 CARTON11/06/2019
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/06/2019
Labeler - First Aid Research Corp. (089405927)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(75983-006)

Revised: 2/2022
Document Id: d8c30b8c-dac8-183a-e053-2a95a90a6a54
Set id: cbd899ca-80da-4a1b-9b32-2148759d9424
Version: 3
Effective Time: 20220224
 
First Aid Research Corp.