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NDC 52412-0400-16 Balmex Diaper Rash 0.113 g/g Details

Balmex Diaper Rash 0.113 g/g

Balmex Diaper Rash is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Randob Labs,Ltd.. The primary component is ZINC OXIDE.

Product Information

NDC	52412-0400
Product ID	52412-400_18af2fdd-d234-4675-afc6-e0bdd19cdbbd
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	Balmex 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	0.113
Active Ingredient Units	g/g
Substance Name	ZINC OXIDE
Labeler Name	Randob Labs,Ltd.
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 52412-0400-16 (52412040016)

Pricing Information	N/A
NDC Package Code	52412-400-16
Billing NDC	52412040016
Package	453 g in 1 JAR (52412-400-16)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f202dd0e-7c61-4ea1-a5f6-e90898366ba3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Zinc Oxide 11.3%	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

When using this product

do not get into 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 immediately.

Directions

change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
apply cream 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

do not use if quality seal is broken
see bottom of carton and or top of tube for lot number and expiration date

SPL UNCLASSIFIED SECTION

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

1-833-389-9450

Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

NEW LOOK-SAME PRODUCT

Balmex®

COMPLETE

PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

✔: Protects against

all 3 leading causes

of diaper rash
✔: Reduces rash in

just 1 diaper change

Pediatrician Recommended

Advanced

Formula

NET WT 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

INGREDIENTS AND APPEARANCE

BALMEX DIAPER RASH

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52412-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.113 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Yellow Wax (UNII: 2ZA36H0S2V)
Benzoic Acid (UNII: 8SKN0B0MIM)
Dimethicone 100 (UNII: RO266O364U)
Soybean Oil (UNII: 241ATL177A)
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)
Methylparaben (UNII: A2I8C7HI9T)
Microcrystalline Wax (UNII: XOF597Q3KY)
Mineral Oil (UNII: T5L8T28FGP)
Oenothera Biennis (UNII: 76UI55V071)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Dexpanthenol (UNII: 1O6C93RI7Z)
Potassium Aspartate (UNII: OC4598NZEQ)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sarcosine (UNII: Z711V88R5F)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Tocopherol (UNII: R0ZB2556P8)
Water (UNII: 059QF0KO0R)
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)
White Wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52412-400-04	1 in 1 CARTON	11/01/2018
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:52412-400-16	453 g in 1 JAR; Type 0: Not a Combination Product	11/01/2018
3	NDC:52412-400-02	1 in 1 CARTON	11/01/2018
3		56 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:52412-400-05	5.1 g in 1 PACKAGE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	04/27/2015

Labeler - Randob Labs,Ltd. (061995007)

Name	Address	ID/FEI	Business Operations
Establishment
KIK HOLDCO COMPANY INC.		243547333	MANUFACTURE(52412-400)

Revised: 11/2018

Document Id: 18af2fdd-d234-4675-afc6-e0bdd19cdbbd

Set id: f202dd0e-7c61-4ea1-a5f6-e90898366ba3

Version: 1

Effective Time: 20181113

Search by Drug Name or NDC

NDC 52412-0400-16 Balmex Diaper Rash 0.113 g/g Details

Balmex Diaper Rash 0.113 g/g

Product Information

Package

Package Images

NDC 52412-0400-16 (52412040016)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f202dd0e-7c61-4ea1-a5f6-e90898366ba3 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions?

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

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