SENSI CARE CLEAR ZINC- dimethicone, zinc oxide cream

SENSI CARE CLEAR ZINC by

Drug Labeling and Warnings

SENSI CARE CLEAR ZINC by is a Otc medication manufactured, distributed, or labeled by ConvaTec Inc., Apex International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENSI CARE CLEAR ZINC

ACTIVE INGREDIENT

Active Ingredients / Purpose

Dimethicone - 5%.........................................Skin Protectant

Zinc Oxide - 5%............................................Skin Protectant

Uses

• Helps treat and prevent diaper rash.
  
• Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

Do not use

• on deep or puncture wounds
• on animal bites
• on serious burns.
  

When using this product do not get into eyes.

Stop use and ask 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 consult a Poison Control Center right away.

Directions

• Change wet and soiled diapers promptly,cleanse the diaper area, and allow to dry.
  
• Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredients

Butylene/Ethylene/Styrene Copolymer, Calamine, Carthamus Tinctorius (Safflower) Oleosomes, Cellulose Gum, Cocos Nucifera (Coconut) Oil, Ethylene/Propylene/Styrene Copolymer, Gelatin, Gossypium Herbaceum (Cotton) Seed Oil, Hydrolyzed Collagen, Lanolin, Microcrystalline Wax, Mineral Oil, Oleic Acid, Pectin, Phenoxyethanol, Punica Granatum Sterols, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Stearic Acid, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

SENSI CARE CLEAR ZINC 2oz/56g (

43553-0007-2)| SENSI CARE CLEAR ZINC 5oz/141g (43553-0007-5)

INGREDIENTS AND APPEARANCE

SENSI CARE CLEAR ZINC 
dimethicone, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43553-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
COCONUT OIL (UNII: Q9L0O73W7L)
GELATIN (UNII: 2G86QN327L)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
LANOLIN (UNII: 7EV65EAW6H)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
OLEIC ACID (UNII: 2UMI9U37CP)
PECTIN (UNII: 89NA02M4RX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)
JOJOBA OIL (UNII: 724GKU717M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43553-0007-2	56 g in 1 TUBE; Type 0: Not a Combination Product	06/12/2014
2	NDC: 43553-0007-5	141 g in 1 TUBE; Type 0: Not a Combination Product	06/12/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/12/2014

Labeler - ConvaTec Inc. (080128290)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International		015226132	manufacture(43553-0007)