Diaper Rash Cream

Diaper Rash Cream
SPL v1
SPL
SPL Set ID b6e209c8-09be-eac2-e053-2a95a90a4751
Route
TOPICAL
Published
Effective Date 2011-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (13 g)
Inactive Ingredients
Water Mineral Oil Petrolatum Cetyl Alcohol Ceteareth-25 Glyceryl Monostearate White Wax Microcrystalline Wax Dimethicone Aloe Vera Leaf Methylparaben Propylparaben Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-30

Description

Zinc Oxide 13%

Purpose

Skin Protection


Medication Information

Purpose

Skin Protection

Description

Zinc Oxide 13%

Use
  • Helps treat and prevent diaper rash
  • Soothes and relieves irritated skin
  • Protects your baby's skin from wetness

Warnings

For external use only

Directions

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area
  • Allow to dry
  • Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged

Carton Label

Active Ingredient

Zinc Oxide 13%

Other Information

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax, Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera), Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Carbomer

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 or symptoms clear up and occur again within a few days.

Keep Out of Reach of Children

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


Structured Label Content

Use
  • Helps treat and prevent diaper rash
  • Soothes and relieves irritated skin
  • Protects your baby's skin from wetness

Purpose

Skin Protection

Warnings

For external use only

Directions

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area
  • Allow to dry
  • Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged

Carton Label

Active Ingredient

Zinc Oxide 13%

Other Information

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax, Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera), Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Carbomer

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)

Condition worsens or does not improve within 7 days or symptoms clear up and occur again within a few 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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