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NDC 52412-0500-12 BALMEX ADULT CARE RASH 0.113 g/g Details

BALMEX ADULT CARE RASH 0.113 g/g

BALMEX ADULT CARE 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	52412-0500
Product ID	52412-500_3b905d74-d3d4-4b83-8c32-3a3ead9d23cc
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 ADULT CARE 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 52412-0500-12 (52412050012)

Pricing Information	N/A
NDC Package Code	52412-500-12
Billing NDC	52412050012
Package	340 g in 1 JAR (52412-500-12)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9443a987-c7b2-4b0d-a9dc-02233135af81 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Zinc Oxide 11.3%	Skin protectant

Uses

helps relieve and prevent rashes and irritation due to wetness from incontinence
protects chafed skin due to irritation and helps seal out wetness

Warnings

For external use only

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens
symptoms persist 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

gently cleanse affected skin
pat dry with a clean, soft cloth or allow to air dry
apply generously to affected area as needed, especially after incontinence episodes
using a dry tissue to remove excess product from skin is most effective

SPL UNCLASSIFIED SECTION

Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021)

SPL UNCLASSIFIED SECTION

For more information please visit

www.BalmexAdult.com

SPL UNCLASSIFIED SECTION

Distributed by RANDOB LABS LTD.

Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Activ

Guard™

NEUTRALIZES

IRRITANTS

Balmex®

ADULTCARE™

RASH CREAM

ZINC OXIDE 11.3%

Soothes &

Protects Skin

From Irritation, Chafing & Rash

Dermatologist Tested

Works in One Use*

Odor-Free

NET WT 3 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

INGREDIENTS AND APPEARANCE

BALMEX ADULT CARE RASH

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52412-500
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
Mineral Oil (UNII: T5L8T28FGP)
Water (UNII: 059QF0KO0R)
Yellow Wax (UNII: 2ZA36H0S2V)
Microcrystalline Wax (UNII: XOF597Q3KY)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Oenothera Biennis (UNII: 76UI55V071)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Dimethicone 100 (UNII: RO266O364U)
Tocopherol (UNII: R0ZB2556P8)
Methylparaben (UNII: A2I8C7HI9T)
Soybean Oil (UNII: 241ATL177A)
Propylparaben (UNII: Z8IX2SC1OH)
Dexpanthenol (UNII: 1O6C93RI7Z)
Sarcosine (UNII: Z711V88R5F)
Benzoic Acid (UNII: 8SKN0B0MIM)
Potassium Aspartate (UNII: OC4598NZEQ)
Potassium Hydroxide (UNII: WZH3C48M4T)
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)
Propylene Glycol (UNII: 6DC9Q167V3)
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:52412-500-03	1 in 1 CARTON	11/01/2018
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:52412-500-12	340 g in 1 JAR; 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(52412-500)

Revised: 11/2018

Document Id: 3b905d74-d3d4-4b83-8c32-3a3ead9d23cc

Set id: 9443a987-c7b2-4b0d-a9dc-02233135af81

Version: 1

Effective Time: 20181113

Search by Drug Name or NDC

NDC 52412-0500-12 BALMEX ADULT CARE RASH 0.113 g/g Details

BALMEX ADULT CARE RASH 0.113 g/g

Product Information

Package

Package Images

NDC 52412-0500-12 (52412050012)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9443a987-c7b2-4b0d-a9dc-02233135af81 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

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