Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 73105da2-ddfe-475b-80b3-7e1786b1f6ea
Route
TOPICAL
Published
Effective Date 2012-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.40 g)
Inactive Ingredients
Talc Apis Mellifera Mineral Oil Tocopherol Sorbitan Sesquioleate Aloe Vera Leaf Methylparaben Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-07-13

Description

Zinc Oxide 40%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 40%

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips
Warnings

For external use only

Directions
  • cleanse the diaper area
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use

over deep or puncture wounds, infections or lacerations

Package Label

Vida Mia Diaper Rash Cream

Active Ingredient

Zinc Oxide 40%

Other Information
  • store at room temperature
Inactive Ingredients

Talc, Vacellin, Bees wax, Dimethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor

if condition worsens or does not improve within 7 days.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips
Purpose

Skin Protectant

Warnings

For external use only

Directions
  • cleanse the diaper area
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use (Do not use)

over deep or puncture wounds, infections or lacerations

Package Label (Package label)

Vida Mia Diaper Rash Cream

Active Ingredient (Active ingredient)

Zinc Oxide 40%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

Talc, Vacellin, Bees wax, Dimethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

When Using This Product (When using this product)

avoid contact with the eyes

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

if condition worsens or does not improve within 7 days.

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.


Advanced Ingredient Data


Raw Label Data

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