De La Cruz ®

De La Cruz ®
SPL v6
SPL
SPL Set ID 5949aa0f-a7cb-453c-81fd-9fa24653a452
Route
TOPICAL
Published
Effective Date 2020-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (1 g) Petrolatum (45 g) Zinc Oxide (40 g)
Inactive Ingredients
Lanolin Water Phenoxyethanol .alpha.-tocopherol Acetate Starch, Corn Lavender Oil Vitamin A Palmitate Cholecalciferol Levomenol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-07-10 Until 2020-11-12

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1
Active ingredients Purpose
Allantoin 1% Skin protectant
Petrolatum 45% Skin protectant
Zinc oxide 40% Skin protectant
Warnings

For external use only.

Questions

1-800-858-3889

Directions
  • change wet and soiled diapers promptly
  • 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
Other Information
  • store at room temperature
Inactive Ingredients

alpha-bisabolol, cholecalciferol, lanolin, lavender oil, phenoxyethanol, retinyl palmitate, tocopheryl acetate, purified water, zea mays (corn) starch

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days
Principal Display Panel 96 G Tube Label

De La Cruz ®

Baby

Diaper Rash

Ointment

3 in 1

Soothes, Heals, Protects

MAXIMUM

STRENGTH

  • Zinc Oxide 40%
  • Mild enough for everyday use
  • No Artificial Fragrances or Colors,

    No Parabens or Phthalates
  • Allergy Tested

NET WT 3.4 OZ (96 g)


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)
Active ingredients Purpose
Allantoin 1% Skin protectant
Petrolatum 45% Skin protectant
Zinc oxide 40% Skin protectant
Warnings

For external use only.

Questions

1-800-858-3889

Directions
  • change wet and soiled diapers promptly
  • 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
Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

alpha-bisabolol, cholecalciferol, lanolin, lavender oil, phenoxyethanol, retinyl palmitate, tocopheryl acetate, purified water, zea mays (corn) starch

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days
Principal Display Panel 96 G Tube Label (PRINCIPAL DISPLAY PANEL - 96 g Tube Label)

De La Cruz ®

Baby

Diaper Rash

Ointment

3 in 1

Soothes, Heals, Protects

MAXIMUM

STRENGTH

  • Zinc Oxide 40%
  • Mild enough for everyday use
  • No Artificial Fragrances or Colors,

    No Parabens or Phthalates
  • Allergy Tested

NET WT 3.4 OZ (96 g)


Advanced Ingredient Data


Raw Label Data

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