ZINC-OXYDE PLUS: Package Insert and Label Information

ZINC-OXYDE PLUS- menthol and 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.

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

  • cleanse skin gently with mild skin cleanser
  • pat dry or allow to air dry
  • apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

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
(click image for full-size original)

ZINC-OXYDE PLUS
menthol, zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75983-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4.4 mg in 1 g
ZINC OXIDE (ZINC CATION) ZINC CATION 206 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CETYL ESTERS WAX
GLYCERIN
GLYCERYL MONOSTEARATE
LANOLIN
POLYOXYL 40 HYDROGENATED CASTOR OIL
PHENOL
SODIUM BICARBONATE
THYMOL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75983-006-57 1 TUBE in 1 CARTON contains a TUBE
1 57 g in 1 TUBE This package is contained within the CARTON (75983-006-57)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 11/06/2019
Labeler — First Aid Research Corp. (089405927)
Registrant — Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
Name Address ID/FEI Operations
Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture (75983-006)

Revised: 11/2019 First Aid Research Corp.

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