BABY LOVE PERSONAL CARE DIAPER RASH- zinc oxide cream

Baby LOVE Personal CARE by

Drug Labeling and Warnings

Baby LOVE Personal CARE by is a Otc medication manufactured, distributed, or labeled by Delta Brands & Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BABY LOVE PERSONAL CARE  DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72133-321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72133-321-45	127 g in 1 TUBE; Type 0: Not a Combination Product	04/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/09/2018

Labeler - Delta Brands & Products LLC (080999173)