Carlesta® Ointment

Manufacturer: Cosette Pharmaceuticals, Inc.
Effective date: 2019-08-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:14:54

Label at a glance#

ProductCarlesta

Active ingredientDIMETHICONE, ZINC OXIDE

Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%
Zinc Oxide 26%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• store at room temperature

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0623-04	GM - Gram	0713-0623	8525a9f3-74fa-4504-93f2-8cf9a6abe31c	1	2012-07-24
0713-0623-32	GM - Gram	0713-0623	54bcb9ce-a24d-41e4-afd6-273633bdc24d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	1
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	1
Cod Liver Oil	INACTIVE INGREDIENT	BBL281NWFG	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
Light Mineral Oil	INACTIVE INGREDIENT	N6K5787QVP	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Polysorbate 40	INACTIVE INGREDIENT	STI11B5A2X	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	1
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Carlesta
Dimethicone, Zinc Oxide
DIMETHICONE
ZINC OXIDE
PETROLATUM
LANOLIN
GLYCERYL MONOSTEARATE
COD LIVER OIL
LIGHT MINERAL OIL
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN
STARCH, CORN
TEA TREE OIL
WATER
POLYSORBATE 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0713-0623	0713-0623-32, 0713-0623-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
PETROLATUM	4T6H12BN9U	IACT
LANOLIN	7EV65EAW6H	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
COD LIVER OIL	BBL281NWFG	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
STARCH, CORN	O8232NY3SJ	IACT
TEA TREE OIL	VIF565UC2G	IACT
WATER	059QF0KO0R	IACT
POLYSORBATE 40	STI11B5A2X	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 275 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Light Mineral Oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM, AUGMENTED / TOPICAL	25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Polysorbate 40	POLYSORBATE 40	STI11B5A2X	LIQUID / TOPICAL	2 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Light Mineral Oil	LIGHT MINERAL OIL	N6K5787QVP	SUPPOSITORY / VAGINAL	1464.9 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Light Mineral Oil	LIGHT MINERAL OIL	N6K5787QVP	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Polysorbate 40	POLYSORBATE 40	STI11B5A2X	ELIXIR / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 7 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Polysorbate 40	POLYSORBATE 40	STI11B5A2X	GEL / TOPICAL		28 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Light Mineral Oil	LIGHT MINERAL OIL	N6K5787QVP	AEROSOL, FOAM / TOPICAL		240 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8fb6adf0-7c69-4892-95de-32a0560c15d1			76faa5a0-30f3-ec10-a565-44c2456fb615	2021-06-26	Warnings	Exact identifier spl set id: 76faa5a0-30f3-ec10-a565-44c2456fb615

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.