BEING WELL BODY DAILY MOISTURIZING- dimethicone lotion 
Save-A-Lot Food Stores Ltd

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.

----------

Active Ingredient
Dimethicone 1.25%

Purpose
Skin protectant

Uses

■Helps prevent and temporarily protects chafed, chapped, or cracked skin

■Helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

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.

Do not use on

■Deep or puncture wounds

■Animal bites

■Serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions Apply as needed

Inactive ingredients avena sativa (oat) kernel flour, benzyl alcohol, ceteareth-20, cetrimonium chloride, cetyl alcohol, FD&C blue no.1, FD&C yellow no.5, FD&C yellow no.6, glycerin, isopropyl palmitate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, triethanolamine, water

image description

BEING WELL BODY  DAILY MOISTURIZING
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-500
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.25 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PETROLATUM (UNII: 4T6H12BN9U)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46994-500-12 355 mL in 1 BOTTLE, PLASTIC
2 NDC:46994-500-18 532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/01/2013
Labeler - Save-A-Lot Food Stores Ltd (095484572)

Revised: 2/2013
Document Id: 6566ae73-8322-4254-85cb-a1bcdf46dbab
Set id: a17ce9e2-ed2e-4ed5-b815-108bf70fd350
Version: 1
Effective Time: 20130218
 
Save-A-Lot Food Stores Ltd