CARLESTA- dimethicone, zinc oxide ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Tilgjengelig fra:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Dimethicone

Sammensetning:

Dimethicone 20 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Skin Protectant • 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

Autorisasjon status:

OTC monograph final

Preparatomtale

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._
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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
CARLESTA
dimethicone, zinc oxide ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 713-0 6 23
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
20 mg in 1 g
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
26 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PETRO LATUM (UNII: 4T6 H