Balmex Diaper Rash Cream

Drug Labeling and Warnings

Drug Details [pdf]

BALMEX DIAPER RASH- zinc oxide cream 
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Balmex Diaper Rash Cream

Balmex Diaper Rash Cream Stick

Active Ingredient 

Zinc oxide 11.3%

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

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens or lasts more than 7 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 anytime when exposure to wet diapers may be prolonged

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 europaea (olive) leaf extract, panthenol potassium aspartate, potassium hydroxide, propylene glycol, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

 

Dist.by Chattem, Inc.
P.O. Box 2219,
Chattanooga,TN 37409-0219
©2009 Chattem, Inc.
*patent pending
0071602-01

 

Balmex Diaper Rash Cream 

Active Ingredient

Zinc oxide 11.3%

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

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens or lasts more than 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 

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 anytime when exposure to wet diapers may be prolonged

Other information

• do not use if quality seal is broken
  
• see bottom of carton for expiration date

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 europaea (olive) leaf extract, panthenol potassium aspartate, potassium hydroxide, propylene glycol, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Datos del Medicamento

Ingrediente activo

Óxido de Cinc 11.3%

Propósito

Protege la Piel

Usos

• ayuda a tratar y prevenir las rozaduras de pañal
  
• protege la piel irritada por las rozaduras de pañal y ayuda a mantener la piel seca
  
• cambie los pañales mojados rápidamente
  
• limpie el área del pañal y deje secar
  
• aplique la crema tan frecuentemente como sea necesario, o con cada cambio de pañal, especialmente a la hora de dormir o en cualquier momento que se tenga contacto con pañales mojados durante un tiempo prolongado

Precauciones

Para uso externo solamente

Cuando use este producto

Evite el contacto con los ojos

Deje de usarlo y consulte a su médico si

La condición empeora o dura más de 7 dias

Mantenga fuera del alcance de los niños.

En caso de consumo accidental, busque ayuda médica o contacte al Centro de Control de Envenenamiento inmediatamente.

Instrucciones de uso

Otra información

• no use si el sello de calidad esta rolo
  
• vea la fecha de caducidad en la parte interior de la caja

Ingredientes no activos

Cera de abeja, acido benzoico, dimeticona, fragancia, aceite de soya (glycine soja), aspartato de magnesio, metilparabeno, cera microcrístalina, aceite mineral, extracto de onagro (oenothera biennis), extracto de hoja de olivo (olea europaea), pantenol, hidróxido de potasio, propilenglicol, propilparabén, sarcosina, aminoácidos de cocil sódico, sesquioleato de sorbitán, cera sintética de abeja, tocolerol, agua (245-230)

Principal Display Panel

NEW!

PATENTED*

Activ

Guard TM 

Balmex®

Diaper Rash Cream Stick

ZINC OXIDE 11.3%

Fast, No Mess

Protection

NET WT 2 OZ (56 g)

0071601-01

Principal Display Panel

NEW!

PATENTED*

Activ

Guard TM 

Balmex®

Diaper Rash Cream Stick

ZINC OXIDE 11.3%

Fast, No Mess

Protection

NET WT 2 OZ (56 g)

0071601-01

Principal Display Panel

PATENTED*

Activ

Guard TM 

NEUTRALIZES IRRITANTS

IN DIRTY DIAPERS

Balmex®

Diaper Rash Cream ZINC OXIDE 11.3%

Crema Para Rozaduras De Pañal con ÓXIDO DE CINC 11.3%

Reduces redness in 1 diaper change

PEDIATRICIAN RECOMMENDED

Soothing Vitamins B5 and E

Gentle on, Easy Off

BALMEX DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0243
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0243-0	56 g in 1 CONTAINER; Type 0: Not a Combination Product	12/15/2008	04/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/15/2008	04/24/2015

BALMEX DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0242
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0242-3	1 in 1 CARTON	12/15/2008	04/24/2015
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0242-0	1 in 1 CARTON	12/15/2008	04/24/2015
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 41167-0242-2	454 g in 1 JAR; Type 0: Not a Combination Product	12/15/2008	04/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/15/2008	04/24/2015

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	LABEL(41167-0243, 41167-0242) , MANUFACTURE(41167-0243, 41167-0242) , PACK(41167-0243, 41167-0242)

Revised: 4/2015

Document Id: 48adb9e1-b842-4129-93e7-c353dfe2a611

34390-5

Set id: 3ff0dc0f-793e-402f-b411-e153a62a0423

Version: 4

Effective Time: 20150424

 

Chattem, Inc.