Desitin Rapid Relief Diaper Rash Cream

Desitin Rapid Relief Diaper Rash Cream

Drug Labeling and Warnings

Drug Details

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DESITIN RAPID RELIEF DIAPER RASH- zinc oxide cream 
Johnson & Johnson Consumer 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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Desitin Rapid Relief Diaper Rash Cream

Drug Facts

Active ingredient

Zinc Oxide 13%

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

  • do not get into 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 day

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
  • Allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

  • Store at 20° to 25°C (68° to 77°F)
  • Protect from freezing
  • May stain clothing

Inactive ingredients

Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Extract , Glycerin , Tropolone, Tocopheryl Acetate, 1,2-Hexanediol Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide, Phenoxyethanol

Questions?

Call toll-free 800-720-3843 or 215-273-8755 (collect)

Distributed in the U.S. by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY

Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

#1 CHOICE OF
PEDIATRICIANS & MOMS

NEW
FORMULA

Desitin®
Rapid Relief

relieves discomfort
in one application

Paraben-free
Fragrance-free          Zinc Oxide Diaper Rash Cream          NET WT 4 Oz (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
DESITIN RAPID RELIEF DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58232-9926
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide130 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Mineral Oil (UNII: T5L8T28FGP)  
Petrolatum (UNII: 4T6H12BN9U)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Dimethicone (UNII: 92RU3N3Y1O)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
PEG-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Glycerin (UNII: PDC6A3C0OX)  
Tropolone (UNII: 7L6DL16P1T)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-9926-03.5 g in 1 PACKET; Type 0: Not a Combination Product10/20/2015
2NDC: 58232-9926-21 in 1 CARTON10/20/2015
257 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 58232-9926-41 in 1 CARTON10/20/2015
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 58232-9926-51 in 1 CARTON10/20/2015
4136 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 58232-9926-61 in 1 CARTON10/20/2015
5170 g in 1 TUBE; Type 0: Not a Combination Product
6NDC: 58232-9926-82 in 1 CARTON10/20/2015
6170 g in 1 TUBE; Type 0: Not a Combination Product
7NDC: 58232-9926-9454 g in 1 JAR; Type 0: Not a Combination Product10/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34710/20/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 5/2016
 
Johnson & Johnson Consumer Inc.


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