PREVISENSE ONCE A DAY MOISTURIZING CREAM- dimethicone cream
Molnlycke Health Care

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.

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PreviSense Once a Day Moisturizing Cream 2oz

Active Ingredients

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
on animal bites
on serious burns

Avoid contact with the 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 this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply as needed

Inactive Ingredients

Bees Wax, Castor Oil, Cetyl PEG/PPG-10/1 Dimethicone, Disodium EDTA, Hydrogenated Castor Oil, Octyl Stearate, Purified Water, Sodium Bisulfite, Sodium Chloride, Sodium Hydroxymethylglycinate, Tocopheryl Acetate, Tribehenin

PreviSense Once a Day Moisturizing Cream 2 oz

PREVISENSE ONCE A DAY MOISTURIZING CREAM
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0234-2240
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
OCTYL STEARATE (UNII: 772Y4UFC8B)
WATER (UNII: 059QF0KO0R)
SODIUM BISULFITE (UNII: TZX5469Z6I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0234-2240-02	59 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2016	12/31/2018

Labeler - Molnlycke Health Care (165301032)

Revised: 12/2018

Document Id: 7d65d0a0-299d-ead0-e053-2a91aa0a411b

Set id: 2bf9961e-9db5-2a2b-e054-00144ff88e88

Version: 3

Effective Time: 20181219

Molnlycke Health Care