SR RENEW - dimethicone cream 
International Brand Management, LLC

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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Drug Facts

Active ingredient

Dimethicone 5.0%

Skin Protectant

Uses

-temporarily protects and help relieve chapped or cracked skin

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. If swallowed, get medical

help or contact a Poison Control Center right away.

Directions

-apply cream liberally as needed.

Other information

-protect from freezing   avoid excessive heat

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).

copy of label

SR RENEW 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69837-310-101 in 1 CARTON
1118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2016
Labeler - International Brand Management, LLC (079794940)
Establishment
NameAddressID/FEIBusiness Operations
International Brand Management, LLC079794940manufacture(69837-310)

Revised: 2/2016
Document Id: 8b911631-65c0-4f92-8e0d-eae041ac595c
Set id: bb3b03cf-9f4a-440f-b854-96f982a7805d
Version: 1
Effective Time: 20160201
 
International Brand Management, LLC