Zinc Oxide Plus

Zinc Oxide Plus
SPL v3
SPL
SPL Set ID cbd899ca-80da-4a1b-9b32-2148759d9424
Route
TOPICAL
Published
Effective Date 2019-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.4 mg) Zinc Cation (206 mg)
Inactive Ingredients
Butylated Hydroxytoluene Cetyl Esters Wax Glycerin Glyceryl Monostearate Lanolin Polyoxyl 40 Hydrogenated Castor Oil Phenol Sodium Bicarbonate Thymol Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-11-06

Description

Menthol 0.44% Zinc Oxide 20.6%

Purpose

External analgesic / Anti-itch Skin protectant / Anorectal astringent


Medication Information

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Description

Menthol 0.44% Zinc Oxide 20.6%

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor

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

Section 51945-4

Warnings

For external use only

• not for deep or puncture wounds 

• avoid contact with eyes

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.
Drug Facts

Questions?

call 516-783-0274

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.6%

Inactive Ingredients

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


Structured Label Content

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor

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

Section 51945-4 (51945-4)

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Warnings

For external use only

• not for deep or puncture wounds 

• avoid contact with eyes

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.
Drug Facts

Questions?

call 516-783-0274

Active Ingredients (Active ingredients)

Menthol 0.44%

Zinc Oxide 20.6%

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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