CARLESTA - dimethicone, zinc oxide ointment 
Cosette Pharmaceuticals, 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.

----------

Carlesta® Ointment

ACTIVE INGREDIENT

Dimethicone 2%
Zinc Oxide 26%

PURPOSE

Skin Protectant

USES

• helps treat and prevent rash associated with the use of absorbent products for adult incontinence
• protects minor skin irritation due to inflammatory skin conditions and helps seal out wetness

WARNINGS

For external use only

When using this product
• avoid contact with the eyes

Stop use and ask a doctor if
• condition worsens or does not improve within 7 days

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• apply liberally as often as necessary especially at bedtime or any time when exposure to soiled absorbent products may be prolonged

OTHER INFORMATION

• store at room temperature

INACTIVE INGREDIENT

butylated hydroxytoluene, cod liver oil, glyceryl monostearate, lanolin, methylparaben, mineral oil, mono- and diglyceride, polysorbate 40, propylparaben, purified water, starch, tea tree oil, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0623-32
Carlesta®
A D U L T  S K I N  P R O T E C T A N T
Net Wt. 4 oz (114 g)
- Formulated especially for adults
- Protection barrier from wetness
- Soothes chafed and irritated skin resulting from adult incontinence

Unit Carton
CARLESTA  
dimethicone, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0623
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE260 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
COD LIVER OIL (UNII: BBL281NWFG)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STARCH, CORN (UNII: O8232NY3SJ)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0713-0623-3256.8 g in 1 TUBE; Type 0: Not a Combination Product09/08/199906/30/2012
2NDC:0713-0623-04114 g in 1 TUBE; Type 0: Not a Combination Product09/08/199906/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/08/199906/30/2012
Labeler - Cosette Pharmaceuticals, Inc. (116918230)
Registrant - Cosette Pharmaceuticals, Inc. (116918230)
Establishment
NameAddressID/FEIBusiness Operations
Cosette Pharmaceuticals, Inc.116918230analysis(0713-0623) , manufacture(0713-0623) , label(0713-0623) , pack(0713-0623)

Revised: 6/2021
 
Cosette Pharmaceuticals, Inc.