Johnsons Medicated (Zinc Oxide) Powder [Johnson & Johnson Consumer Inc.] -

JOHNSONS MEDICATED (ZINC OXIDE) POWDER [JOHNSON & JOHNSON CONSUMER INC.]
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NDC	69968-0493-1
Set ID	253aef62-4d29-4f22-b6d7-98c5e9510f44
Category	HUMAN OTC DRUG LABEL
Packager	Johnson & Johnson Consumer Inc.
Generic Name
Product Class
Product Number
Application Number	PART347

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Zinc Oxide (10%)1
Purpose

Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Protects chafed skin due to diaper rash and helps seal out wetness
Warnings

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

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.

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

Zea Mays (Corn) Starch1, Fragrance

1

naturally-derived ingredients
Questions ?

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

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)

INGREDIENTS AND APPEARANCE

JOHNSONS MEDICATED
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0493
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0493-1	425 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2005	07/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/01/2005	07/28/2022

Labeler - Johnson & Johnson Consumer Inc. (002347102)

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