BUYBUYBABY QUICK RELIEF DIAPER RASH CREAM- zinc oxide cream 
Harmon Stores 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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buybuyBABY

Active ingredient

Zinc Oxide, 13.0%

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 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

-allow to dry  -apply cream liberally as often as necessary, with each diaper

change, especially at bedtime or at any time when exposure to wet diapers may

be prolonged

Other information

-store at 20 to 25 C    (68 to 77 F)

Inactive ingredients

aloe barbadensis leaf juice, beeswax, dimethicone,

magnesium sulfate, methylparaben, microcrystalline wax,

mineral oil, PEG-30 dipolyhydroxystearate, petrolatum,

phenoxyethanol, polyglyceryl-3 diostearate,

potassium hydroxide, proprylparaben, sorbitan,

sesquioleate, tocopheryl acetate (vitamin E), water

Maximum Strength Diaper Rash Paste provides maximum strength relief

overnight for baby's delicate skin. This rich and dermatologist-tested

formula instantly forms a protection layer

on your baby's skin to soothe and relieve discomfort caused

by diaper rash.

image description

BUYBUYBABY  QUICK RELIEF DIAPER RASH CREAM
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.69 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-113-171 in 1 CARTON12/07/201606/30/2020
1NDC:63940-113-16113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/07/201606/30/2020
Labeler - Harmon Stores Inc. (804085293)

Revised: 6/2023
 
Harmon Stores Inc.