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Carlesta

G&W Laboratories, Inc.
G&W Laboratories, Inc.

Carlesta® Ointment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 Type Human otc drug label Item Code (Source) NDC:0713-0623
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 20 mg
Zinc Oxide Zinc oxide 260 mg

Inactive Ingredients

Ingredient Name Strength
petrolatum
LANOLIN
GLYCERYL MONOSTEARATE
COD LIVER OIL
LIGHT MINERAL OIL
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN
STARCH, CORN
TEA TREE OIL
water
POLYSORBATE 40

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0713-0623-32 56.8 in 1 TUBE
2 NDC:0713-0623-04 114 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 1999-09-08


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Be sure to consult your doctor before taking any medication!
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