BABY LOVE PERSONAL CARE DIAPER RASH- zinc oxide cream 
Delta Brands & Products LLC

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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Drug Facts

Active Ingredient

Zinc oxide 13%

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash

■ soothes and relieves irritated skin

■ protects your baby's skin from wetness

Warnings

For external use only

When using this product

■ avoid contact with eyes

Stop use and ask a doctor if

■ condition worsens or does not improve within 7 days or symptoms clear up and occur again in 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 ■ ointment should be applied at every diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

■ store at 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

water, mineral oil, petrolatum, yellow wax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxysterate, phenoxyethanol, potassium hydroxide, alpha-tocopherol acetate, aloe vera extract

Package Label

Package Label

BABY LOVE PERSONAL CARE  DIAPER RASH
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-321-45127 g in 1 TUBE; Type 0: Not a Combination Product04/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/09/2018
Labeler - Delta Brands & Products LLC (080999173)

Revised: 4/2018
Document Id: 69c1fbc0-825c-1e44-e053-2a91aa0a44c5
Set id: 69c1db68-508a-e6e1-e053-2a91aa0a8568
Version: 1
Effective Time: 20180413
 
Delta Brands & Products LLC