Johnsons medicated

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:12:25

Label at a glance#

ProductJohnsons medicated
Active ingredientZinc oxide
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to diaper area.

Storage and handling

Do not use if quality seal is broken. Avoid contact with open flame. Close tightly after use. Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (10%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only. Keep away from face and mouth to avoid inhalation which can cause breathing problems.

OTC - STOP USE SECTION

Avoid contact with 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to diaper area.

Other information

STORAGE AND HANDLING SECTION

  • Do not use if quality seal is broken.
  • Avoid contact with open flame.
  • Close tightly after use.
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Zea Mays (Corn) Starch1, Fragrance

1 naturally-derived ingredients

Questions ?

OTC - QUESTIONS SECTION

Call toll free 866-JNJ-BABY or 215-273-8755 (collect).

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 425 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY
mildness
PROVEN®

Johnson's®

medicated
powder

zinc oxide skin protectant/with natural
cornstarch/treats & soothes irritated skin

no parabens, phthalates or dyes

Johnson & Johnson

15 OZ (425g)

Principal Display Panel - 425 g Bottle Label
Principal Display Panel - 425 g Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-049369968-0493-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc oxideSOI2LOH54ZACTIB
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0a92b322-c7c4-4ff6-b9e4-ce7f15c72eba253aef62-4d29-4f22-b6d7-98c5e9510f442020-10-02WarningsExact identifier
spl id: 0a92b322-c7c4-4ff6-b9e4-ce7f15c72eba
spl set id: 253aef62-4d29-4f22-b6d7-98c5e9510f44

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.