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NDC 52412-0450-35 BALMEX MULTI-PURPOSE 511 mg/g Details

BALMEX MULTI-PURPOSE 511 mg/g

BALMEX MULTI-PURPOSE is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Randob Labs,Ltd.. The primary component is PETROLATUM.

Product Information

NDC	52412-0450
Product ID	52412-450_8460153a-29a3-4b1e-8e15-c1be1176e97c
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 MULTI-PURPOSE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	511
Active Ingredient Units	mg/g
Substance Name	PETROLATUM
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 52412-0450-35 (52412045035)

Pricing Information	N/A
NDC Package Code	52412-450-35
Billing NDC	52412045035
Package	99 g in 1 TUBE (52412-450-35)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 83a9ba1a-b708-47e2-a4a3-ef847e1bb792 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Petrolatum 51.1%	Skin protectant

Uses

temporarily protects minor
- cuts
- scrapes
- burns
temporarily protects and helps relieve chapped or cracked skin
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.

Do not use on

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

apply as needed
change wet or soiled diapers promptly, cleanse the diaper area, and 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

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

SPL UNCLASSIFIED SECTION

Inactive ingredients

acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)

Questions?

1-833-389-9450

SPL UNCLASSIFIED SECTION

Distributed by RANDOB LABS LTD.

Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 99 g Tube Label

NEW LOOK-SAME PRODUCT

Balmex®

MULTI-PURPOSE

HEALING OINTMENT

Skin Protectant-Petrolatum 51.1%

From diaper rash to

chapped, chafed skin

✔: Heals, protects & soothes
✔: 7 healing moisturizers

plus Vitamin A & Vitamin D
✔: Clear and easy to apply

Pediatrician Recommended

NET WT

3.5 OZ

(99 g)

Principal Display Panel - 99 g Tube Label

INGREDIENTS AND APPEARANCE

BALMEX MULTI-PURPOSE

petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52412-450
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	511 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Vachellia Farnesiana Flower (UNII: 8487B3MG6D)
Allantoin (UNII: 344S277G0Z)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Chamomile (UNII: FGL3685T2X)
Cholecalciferol (UNII: 1C6V77QF41)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Cyclomethicone 6 (UNII: XHK3U310BA)
Dimethicone 200 (UNII: RGS4T2AS00)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)
Mineral Oil (UNII: T5L8T28FGP)
High Density Polyethylene (UNII: UG00KM4WR7)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Rosemary (UNII: IJ67X351P9)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
.alpha.-tocopherol Acetate, Dl- (UNII: WR1WPI7EW8)
Corn Oil (UNII: 8470G57WFM)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52412-450-35	99 g in 1 TUBE; 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(52412-450)

Revised: 11/2018

Document Id: 8460153a-29a3-4b1e-8e15-c1be1176e97c

Set id: 83a9ba1a-b708-47e2-a4a3-ef847e1bb792

Version: 1

Effective Time: 20181113

Search by Drug Name or NDC

NDC 52412-0450-35 BALMEX MULTI-PURPOSE 511 mg/g Details

BALMEX MULTI-PURPOSE 511 mg/g

Product Information

Package

Package Images

NDC 52412-0450-35 (52412045035)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 83a9ba1a-b708-47e2-a4a3-ef847e1bb792 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

When using this product

Stop use and ask a doctor if

Do not use on

Directions

Other information

SPL UNCLASSIFIED SECTION

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 99 g Tube Label

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