JOHNSONS MEDICATED- zinc oxide powder

Johnsons medicated by

Drug Labeling and Warnings

Johnsons medicated by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

Labeler - Johnson & Johnson Consumer Inc. (002347102)