Yaliira Pak (Page 2 of 2)

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General).

DOSAGE AND ADMINISTRATION

Apply a thin film to the affected area two to three times daily.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication.

The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply Triamcinolone Acetonide Ointment under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes:

15 g tube – NDC 52565-014-15

80 g tube – NDC 52565-014-80

1 lb (454 g) jar – NDC 52565-014-26

STORAGE

Store at 20° — 25°C (68° — 77°F). [see USP Controlled Room Temperature]

Teligent Pharma, Inc.
Buena, New Jersey 08310

Rev. 04/16

Skin Repair Complex (dimethicone)

Active ingredient

Dimethicone 5.0%

Purpose

Skin Protectant

Uses

■ temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

■ apply cream liberally as needed

Other information

■ protect from freezing ■ avoid excessive heat

Inactive ingredients

Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex ® [consisting of: bisabolol, calcium pantothenate (vitamin B5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3 ), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

Yaliira Pak™ — carton:

Packaged in the USA by:
Shoreline Pharmaceuticals, Inc.
Panorama City, CA 91402
For questions or information
call: 818-643-4237

Rev. 36774

image description
(click image for full-size original)
YALIIRA PAK
triamcinolone acetonide, dimethicone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69621-846
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69621-846-00 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 80 g
Part 2 1 TUBE 118 mL
Part 1 of 2
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide ointment
Product Information
Item Code (Source) NDC:52565-014
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
light mineral oil
petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52565-014-80 80 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205373
Part 2 of 2
SKIN REPAIR COMPLEX
dimethicone cream
Product Information
Item Code (Source) NDC:59088-333
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHLORPHENESIN
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER
KUKUI NUT OIL
ALOE VERA LEAF
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
SAFFLOWER OIL
CETYL ALCOHOL
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
LEVOMENOL
CALCIUM PANTOTHENATE
CARTHAMUS TINCTORIUS SEED OLEOSOMES
MALTODEXTRIN
NIACINAMIDE
PYRIDOXINE HYDROCHLORIDE
SILICON DIOXIDE
SODIUM ASCORBYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
GINGER
PEG-100 STEARATE
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
PHENOXYETHANOL
WATER
HYALURONATE SODIUM
STEARIC ACID
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-333-08 118 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205373 12/29/2016
Labeler — Shoreline Pharmaceuticals, Inc. (078542781)

Revised: 12/2016 Shoreline Pharmaceuticals, Inc.

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