LBRI PURE N NATURAL DIAPER- zinc oxide cream

LBri Pure N Natural Diaper by

Drug Labeling and Warnings

LBri Pure N Natural Diaper by is a Otc medication manufactured, distributed, or labeled by L'Bri Health and Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient:

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash.
• Protects chafed skin associated with diaper rash and helps protect from wetness.

Warnings

• For external use only

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

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Octyl Palmitate, Parfum (Natural Fragrace), Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohl, Tocopheryl Acetate (Vitamin E).

Other information

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

INGREDIENTS AND APPEARANCE

LBRI PURE N NATURAL DIAPER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71238-857
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71238-857-00	1 in 1 BOX	10/12/2017
1		60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/12/2017

Labeler - L'Bri Health and Beauty (139751148)