Sure ResultTAC Pak (Page 2 of 2)

Silicone Tape

Silicone Tape

Uses
• To be applied to wounds or scars as a protective silicone barrier.
• As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers.
• As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care

Precautions
• Do not use if you are allergic to silicone
• Keep out of reach of children

Directions for use
• Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours.

copy of label
(click image for full-size original)

Established Pharmacological Class
Substance Pharmacological Class
Silicone Tapetape and bandage, adhesivetape and bandage, adhesive Tape And Bandage, Adhesive
SURE RESULTTAC PAK
triamcinolone acetonide, dimethicone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69837-003
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69837-003-02 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 80 g
Part 2 1 CARTON 118 mL
Part 3 1 BOX 1
Part 1 of 3
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide cream
Product Information
Item Code (Source) NDC:67877-251
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
Packaging
# Item Code Package Description Multilevel Packaging
1 1 TUBE in 1 KIT contains a TUBE (67877-251-80)
1 NDC:67877-251-80 80 g in 1 TUBE This package is contained within the KIT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088042 04/01/2012
Part 2 of 3
SR RENEW
dimethicone cream
Product Information
Item Code (Source) NDC:69837-310
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
ALOE VERA LEAF
WATER
CETYL ALCOHOL
DIETHANOLAMINE CETYL PHOSPHATE
ETHYLHEXYLGLYCERIN
GLYCERYL MONOSTEARATE
C13-14 ISOPARAFFIN
LAURETH-7
ETHYLHEXYL PALMITATE
PEG-100 STEARATE
PHENOXYETHANOL
POLYACRYLAMIDE (10000 MW)
POLYSORBATE 20
PROPYLENE GLYCOL
STEARIC ACID
.ALPHA.-TOCOPHEROL ACETATE, DL-
Packaging
# Item Code Package Description Multilevel Packaging
1 1 CARTON in 1 KIT contains a CARTON (69837-310-10)
1 NDC:69837-310-10 118 mL in 1 CARTON This package is contained within the KIT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/02/2016
Part 3 of 3
SILICONE TAPETAPE AND BANDAGE, ADHESIVE TAPE AND BANDAGE, ADHESIVE
Product Information
Item Code (Source) GS1:30707387763634
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOX in 1 KIT contains a BOX (30707387763634)
1 GS1:30707387763634 1 in 1 BOX This package is contained within the KIT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
exempt device KGX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088042 02/02/2016
Labeler — International Brand Management, LLC (079794940)
Establishment
Name Address ID/FEI Operations
International Brand Management, LLC 079794940 manufacture (69837-310), pack (69837-003)

Revised: 03/2016 International Brand Management, LLC

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