medpura

medpura
SPL v5
SPL
SPL Set ID 3a63aaea-087e-4115-8478-64d416e6085f
Route
topical
Published
Effective Date 2023-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (20 g)
Inactive Ingredients
aloe vera leaf mineral oil white petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2024-09-13

Purpose

Skin Protectant

Description

Zinc Oxide 20%


Medication Information

Warnings

For External Use Only

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
Purpose

Skin Protectant

Directions
  • change wet or soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information
  • store at room temperature 20˚-25˚C (68˚-77˚F)
  • may stain clothing
Inactive Ingredients

alovera gel, mineral oil, white petrolatum

Description

Zinc Oxide 20%

Section 51945-4

Active Ingredient

Zinc Oxide 20%

Questions and Comments?

Call toll-free 1-877-225-6999

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Warnings

For External Use Only

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
Purpose

Skin Protectant

Directions
  • change wet or soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information
  • store at room temperature 20˚-25˚C (68˚-77˚F)
  • may stain clothing
Inactive Ingredients

alovera gel, mineral oil, white petrolatum

Section 51945-4 (51945-4)

Active Ingredient

Zinc Oxide 20%

Questions and Comments?

Call toll-free 1-877-225-6999

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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