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NDC 50573-0011-01 Crema Cero Zinc Oxide Skin Protectant Diaper Rash Baby Original Formula 49 mg/g Details

Crema Cero Zinc Oxide Skin Protectant Diaper Rash Baby Original Formula 49 mg/g

Crema Cero Zinc Oxide Skin Protectant Diaper Rash Baby Original Formula is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Laboratorios Cero S.A. The primary component is ZINC OXIDE.

Product Information

NDC	50573-0011
Product ID	50573-0011_c5fa2a4c-84c8-33e6-e053-2a95a90adc8a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Crema Cero Zinc Oxide Skin Protectant Diaper Rash Baby Original Formula
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	49
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	Laboratorios Cero S.A
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 50573-0011-01 (50573001101)

Pricing Information	N/A
NDC Package Code	50573-0011-1
Billing NDC	50573001101
Package	110 g in 1 BOTTLE (50573-0011-1)
Marketing Start Date	2021-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c1708f58-3f1f-449f-e053-2a95a90aa4d4 Details

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:

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
CASTOR OIL (UNII: D5340Y2I9G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50573-0011-1	110 g in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2021	04/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/30/2021	04/30/2024

Labeler - Laboratorios Cero S.A (880165766)

Revised: 6/2021

Document Id: c5fa2a4c-84c8-33e6-e053-2a95a90adc8a

Set id: c1708f58-3f1f-449f-e053-2a95a90aa4d4

Version: 3

Effective Time: 20210630