SURE RESULT SR RENEW- dimethicone cream

Sure Result SR Renew by

Drug Labeling and Warnings

Sure Result SR Renew by is a Otc medication manufactured, distributed, or labeled by International Brand Management, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Dimethicone 5.0%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Uses

-temporarily protects and help relieve chapped or cracked skin

WARNINGS

Warnings

For external use only

Do not use on  -deep or puncture wounds   -animal bites

-serious burns

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

-apply cream liberally as needed.

STORAGE AND HANDLING

Other information

-protect from freezing   avoid excessive heat

INACTIVE INGREDIENT

Inactive Ingredients  Aloe Barbadensis Leaf (Aloe Vera Gel)

Juice, Aqua (Deionized Water), Cetyl Alcohol, DEA-Cetyl

Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glyceryl

Stearate SE, C13-14 Isoparaffin, Laureth-7, Octyl Palmitate,

PEG-100 Stearate, Phenoxyethanol, Polyacrylamide,

Polysorbate-20, Propylene Glycol, Stearic Acid, Tocopheryl

Acetate (Vitamin E).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SURE RESULT SR RENEW 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69837-410
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69837-410-10	1 in 1 CARTON	06/23/2017
1		118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2016

Labeler - International Brand Management, LLC (079794940)

Establishment
Name	Address	ID/FEI	Business Operations
International Brand Management, LLC		079794940	manufacture(69837-410)