Crema Cero Zinc Oxide Skin Protectant Diaper Rash Baby Original Formula: Package Insert and Label Information

CREMA CERO ZINC OXIDE SKIN PROTECTANT DIAPER RASH BABY ORIGINAL FORMULA- zinc oxide ointment
Laboratorios Cero S.A

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Zinc oxide 4.9%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects minor skin irritation due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or 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.

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area and 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 in a fresh place protected from sunlight
  • this product contains lanolin; this substance can cause irritation in people with allergies

Inactive ingredients

petrolatum, lanolin, castor (Ricinus communis) seed oil, fragrance (parfum)

Package Labeling:

Bottle
(click image for full-size original)

CREMA CERO ZINC OXIDE SKIN PROTECTANT DIAPER RASH BABY ORIGINAL FORMULA
zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50573-0011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 49 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
LANOLIN
CASTOR OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50573-0011-1 110 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/30/2021 04/30/2024
Labeler — Laboratorios Cero S.A (880165766)

Revised: 06/2021 Laboratorios Cero S.A

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