Quinixil (Page 4 of 4)

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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Directions

  • Apply as needed
  • Change wet and soiled diapers, garments, and linens promptly
  • Cleanse the affected area and allow to dry
  • Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Inactive ingredients

water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben

QUESTION OR COMMENTS?

1 800 876-1261

Dimethicone packaging

The packaging for Dimethicone is shown below.

Skin Protectant
Contains 5% Dimethicone
For treatment and prevention of incontinence-associated dermatitis
Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips
Non-irritating, fragrance-free
Pediatric tested
CHG Compatible
Does not clog briefs
Smith & Nephew
Securaâ—Š
Dimethicone Protectant

Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, EnglandCertain marks reg’d in U.S. Pat and Tm Off.

image of 4 fl oz label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

The Quinixil package is shown below:

Quinosone Packaging
(click image for full-size original)
QUINIXIL mometasone furoate and dimethicone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-601
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72835-601-02 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 45 g
Part 2 1 TUBE 114 g
Part 1 of 2
MOMETASONE FUROATE mometasone furoate cream
Product Information
Item Code (Source) NDC:0713-0634
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mometasone Furoate (MOMETASONE) Mometasone Furoate 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Hexylene Glycol
Phosphoric Acid
Propylene Glycol Stearate
Stearyl Alcohol
Titanium Dioxide
White Wax
Petrolatum
WATER
Polyoxyl 20 Cetostearyl Ether
Aluminum Starch Octenylsuccinate
Product Characteristics
Color white (off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0634-37 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (0713-0634-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077447
Part 2 of 2
SECURA DIMETHICONE PROTECTANT dimethicone cream
Product Information
Item Code (Source) NDC:69740-322
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
ISOPROPYL PALMITATE
METHYLPARABEN
PARAFFIN
PETROLATUM
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM CHLORIDE
WATER
YELLOW WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69740-322-00 114 g 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 ANDA076216 06/03/2019
Labeler — V2 Pharma, LLC (102457346)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 MANUFACTURE (69740-322)
Establishment
Name Address ID/FEI Operations
Smith & Nephew Medical Ltd 125458849 label (69740-322)
Establishment
Name Address ID/FEI Operations
G&W Laboratories, Inc. 079763718 analysis (0713-0634), manufacture (0713-0634), label (0713-0634), pack (0713-0634)
Establishment
Name Address ID/FEI Operations
V2 Pharma, LLC 102457346 relabel (72835-601)

Revised: 01/2022 V2 Pharma, LLC

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