ZINC-OXYDE PLUS- menthol, zinc oxide ointment

ZINC-OXYDE PLUS by

Drug Labeling and Warnings

ZINC-OXYDE PLUS by is a Otc medication manufactured, distributed, or labeled by First Aid Research Corp., Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC-OXYDE PLUS 
menthol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.4 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	206 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-006-57	1 in 1 CARTON	11/06/2019
1		57 g in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(75983-006)