Balmex Adult Care Rash Cream

Balmex Adult Care Rash by

Drug Labeling and Warnings

Balmex Adult Care Rash by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BALMEX ADULT CARE 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 Adult Care Rash Cream

Active Ingredient 

Zinc oxide 11.3%

Purpose

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

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)

 

Distributed by: CHATTEM, INC.
P.O. Box 2219, Chattanooga, TN 37409-0219
©2012 Chattem, Inc.       0042308-01

Principal Display Panel

NEW!
Balmex®
ADULT CARETM RASH CREAM
ZINC OXIDE 11.3% NEW WT 3 OZ (85G)

Principal Display Panel

NEW!
Balmex®
ADULT CARETM RASH CREAM
ZINC OXIDE 11.3% NEW WT 3 OZ (85G)

BALMEX ADULT CARE RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0244
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
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
METHYLPARABEN (UNII: A2I8C7HI9T)
SOYBEAN OIL (UNII: 241ATL177A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PANTHENOL (UNII: WV9CM0O67Z)
SARCOSINE (UNII: Z711V88R5F)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0244-0	1 in 1 CARTON	12/01/2012	10/01/2018
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0244-5	340 g in 1 JAR; Type 0: Not a Combination Product	12/01/2012	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2012	10/01/2018

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	MANUFACTURE(41167-0244) , PACK(41167-0244)

Revised: 12/2012

Document Id: 658d5381-3335-4bb4-9892-409aeb484451

34390-5

Set id: ac21fd6f-a5de-43ab-a4b8-ad7036c33d78

Version: 4

Effective Time: 20121201

 

Chattem, Inc.