FORMULA 21 DIAPER RASH - zinc oxide cream 
DRA Bello Products, Inc.

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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Formula 21 Diaper Rash Cream

Active Ingredient

Zinc Oxide 25%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash. Protects minor skin irritation due to diaper rash and helps protect from wetness.

Warnings

For external use only.

When using this product

Do not get in eyes.

Stop use and as doctor if

  • conditions worsen
  • symptoms last more than 7 days or clear up and return again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply product liberally as often as necessary, with each diaper change especially at bedtime or any time when exposure to wet diapers may be prolonged.

Inactive Ingredients

Glycerin, Purified Water, Talc

Product Label

Formula 21
Zinc Oxide 25%

Skin Protectant

Not Greasy!

Protector

Diaper Rash - Rapid Relief- Shake before use - Cream

1 fl. oz. (30ml)

Distributed by DRA Bello Products, Inc.
1627 Gessner Dr. Suite 3
Houston TX 77080

www.drabello.tv

713-932-9100


Diaper Rash Cream



Diaper Rash Cream




FORMULA 21 DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42416-0021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE25 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42416-0021-130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/26/2012
Labeler - DRA Bello Products, Inc. (078272165)

Revised: 1/2012
Document Id: 3bd6abd3-df25-4022-ad4e-a610b77c897d
Set id: ed9a74f0-6a38-49a2-93c0-44bf61a9e836
Version: 1
Effective Time: 20120124
 
DRA Bello Products, Inc.