SR RENEW- dimethicone cream

SR Renew by

Drug Labeling and Warnings

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

SR RENEW 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69837-310
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: 69837-310-10	1 in 1 CARTON
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(69837-310)