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NDC 67234-0001-01 Natureplex Diaper Rash 400 mg/g Details

Natureplex Diaper Rash 400 mg/g

Natureplex Diaper Rash is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Natureplex LLC. The primary component is ZINC OXIDE.

Product Information

NDC	67234-0001
Product ID	67234-001_aa9ba666-5b61-46ec-bd97-a6e98a9c4a70
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	Natureplex Diaper Rash
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	400
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	Natureplex LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 67234-0001-01 (67234000101)

Pricing Information	N/A
NDC Package Code	67234-001-01
Billing NDC	67234000101
Package	1 TUBE in 1 BOX (67234-001-01) / 42.5 g in 1 TUBE
Marketing Start Date	2005-01-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 41fe8db3-727c-4bbe-a5ea-62efee4b97b0 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 40%

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.

Avoid contact with 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: 800-222-1222.

Directions

change wet and soiled diapers promptly
cleanse the diaper area
allow to dry
apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

Natureplex™

Diaper Rash Cream

40% Zinc Oxide with Aloe

for

babies

NET WT. 1.5 Oz. (42.5g)

Principal Display Panel - 42.5 g Tube Box

INGREDIENTS AND APPEARANCE

NATUREPLEX DIAPER RASH

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67234-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCOA BUTTER (UNII: 512OYT1CRR)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67234-001-01	1 in 1 BOX	01/02/2005
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	01/02/2005

Labeler - Natureplex LLC (062808196)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(67234-001)

Revised: 9/2018

Document Id: aa9ba666-5b61-46ec-bd97-a6e98a9c4a70

Set id: 41fe8db3-727c-4bbe-a5ea-62efee4b97b0

Version: 3

Effective Time: 20180904