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NDC 71238-0857-00 LBri Pure N Natural Diaper 200 mg/mL Details

LBri Pure N Natural Diaper 200 mg/mL

LBri Pure N Natural Diaper is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by L'Bri Health and Beauty. The primary component is ZINC OXIDE.

Product Information

NDC	71238-0857
Product ID	71238-857_5b5a74a5-b522-0776-e053-2991aa0ab5b2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LBri Pure N Natural Diaper
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	L'Bri Health and Beauty
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71238-0857-00 (71238085700)

Pricing Information	N/A
NDC Package Code	71238-857-00
Billing NDC	71238085700
Package	1 BOTTLE in 1 BOX (71238-857-00) / 60 mL in 1 BOTTLE
Marketing Start Date	2017-10-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 999fe072-48cf-43e2-9a1a-3b13dc0c3e83 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/12/2017

Labeler - L'Bri Health and Beauty (139751148)

Revised: 10/2017

Document Id: 5b5a74a5-b522-0776-e053-2991aa0ab5b2

Set id: 999fe072-48cf-43e2-9a1a-3b13dc0c3e83

Version: 1

Effective Time: 20171012