MAXIMUM STRENGTH DIAPER RASH- zinc oxide ointment ointment 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Package label

Tube label

Tube label

MAXIMUM STRENGTH DIAPER RASH 
zinc oxide ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-849
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-849-04113 g in 1 TUBE; Type 0: Not a Combination Product07/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/22/2016
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(59779-849)

Revised: 1/2021
Document Id: 5a72851c-54de-4054-b83b-0fcb072a5493
Set id: c6f28076-0ffc-4850-b544-656532355537
Version: 3
Effective Time: 20210129
 
CVS Pharmacy