Your browser does not support JavaScript! BEING WELL BODY DAILY MOISTURIZING (DIMETHICONE) LOTION [SAVE-A-LOT FOOD STORES LTD]
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BEING WELL BODY DAILY MOISTURIZING (dimethicone) lotion
[Save-A-Lot Food Stores Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AVENA SATIVA FLOWERING TOP 
BENZYL ALCOHOL 
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 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:46994-500-12355 mL in 1 BOTTLE, PLASTIC
2NDC:46994-500-18532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2013
Labeler - Save-A-Lot Food Stores Ltd (095484572)

Revised: 02/2013
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

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