MAXIMUM STRENGTH DIAPER RASH- zinc oxide ointment ointment

Maximum Strength Diaper Rash by

Drug Labeling and Warnings

Maximum Strength Diaper Rash by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide, 40%

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.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens or does not improve after 7 days

Keep out of reach of children

to prevent accidential ingestion.  If swallowed, seek medical help or call Poison Control Center immediately.

Directions for Use

change wet and soiled diaper immediately, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary with each diaper change and especially when exposured to wet diapers for a prolonged period of time, such as bedtime

Other information

Storage temperature: not to exceed 30oC (86oF),

Remove foil seal from the tube's tip,

Use with infants, children, and adults,

Will stain clothing and fabric

Inactive ingredients

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

Package label

Tube label

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH DIAPER RASH 
zinc oxide ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-849
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)	31 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP)	20 g  in 100 g
PARAFFIN (UNII: I9O0E3H2ZE)	1 g  in 100 g
CASTOR OIL (UNII: D5340Y2I9G)	3.5 g  in 100 g
BALSAM PERU (UNII: 8P5F881OCY)	4.5 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-849-04	113 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/22/2016

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(59779-849)