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

Purpose

Skin Protection

Description

Zinc Oxide 13%


Medication Information

Warnings

For external use only

Purpose

Skin Protection

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

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

Description

Zinc Oxide 13%

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

Carton Label

Active Ingredient

Zinc Oxide 13%

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

Warnings

For external use only

Purpose

Skin Protection

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

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

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

Carton Label

Active Ingredient

Zinc Oxide 13%

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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