CARLESTA- dimethicone, zinc oxide ointment

Carlesta by

Drug Labeling and Warnings

Carlesta by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CARLESTA  
dimethicone, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0623
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	260 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0713-0623-32	56.8 g in 1 TUBE; Type 0: Not a Combination Product	09/08/1999
2	NDC: 0713-0623-04	114 g in 1 TUBE; Type 0: Not a Combination Product	09/08/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/08/1999

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

Establishment
Name	Address	ID/FEI	Business Operations
Cosette Pharmaceuticals, Inc.		116918230	analysis(0713-0623) , manufacture(0713-0623) , label(0713-0623) , pack(0713-0623)