Label: SECURA DIMETHICONE PROTECTANT- dimethicone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 69740-322-00, 69740-322-01 - Packager: Smith & Nephew Medical Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTION OR COMMENTS?
-
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g)
Item #59435000
NDC 69740-322-01
Dimethicone Protectant
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
Secura◊
Dimethicone Protectant
Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England
Certain marks reg'd in U.S. Pat and Tm Off.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (114 g)
Item #59432200
NDC 69740-322-00
Dimethicone Protectant
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
Secura◊
Dimethicone Protectant
Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England.
www.smith-nephew.com
Trademark of Smith & Nephew.
Certain marks reg'd U.S. Pat and Tm. Off.
-
INGREDIENTS AND APPEARANCE
SECURA DIMETHICONE PROTECTANT
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-322 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) 1.7 mg in 1 g ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 45.1 mg in 1 g METHYLPARABEN (UNII: A2I8C7HI9T) 2 mg in 1 g PARAFFIN (UNII: I9O0E3H2ZE) 5 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) 90 mg in 1 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 20 mg in 1 g PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.5 mg in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 8 mg in 1 g WATER (UNII: 059QF0KO0R) 717.8 mg in 1 g YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69740-322-01 3.5 g in 1.0 PACKET; Type 0: Not a Combination Product 08/01/2005 2 NDC:69740-322-00 114 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2005 Labeler - Smith & Nephew Medical Ltd (216344051) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 MANUFACTURE(69740-322)