BATHSCRIPTIONS DAILY MOISTURIZING- dimethicone lotion 
Donegal Bay 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.

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Daily Moisturizing Lotion

Active Ingredient:

Dimethicone 2.0%

Purpose:

Skin Protectant

Uses:

Helps prevent and temporarily protects chafted, chapped or cracked skin. Helps prevent and protect from the drying effect 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 or if symptoms last for 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 immediately

Direction:

Apply as needed

Inactive Ingredients:

Water, Isopropyl Palmitate, Avena sativa (Oat) Flour, Cetyl Alcohol, Glycerin, Distearyldimonium Chloride, Benzyl Alcohol, Sodium Chloride

image description

BATHSCRIPTIONS DAILY MOISTURIZING 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70990-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70990-001-01200 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/12/2016
Labeler - Donegal Bay Ltd (068443618)
Registrant - Donegal Bay Ltd (068443618)
Establishment
NameAddressID/FEIBusiness Operations
HANGZHOU KARIC COMMODITIES CO., LTD526884335manufacture(70990-001)

Revised: 10/2016
Document Id: 60f8e51d-8874-4698-9d8d-f3ca74d01785
Set id: 1e0d1255-d97a-439d-84d3-605bd80ba180
Version: 1
Effective Time: 20161012
 
Donegal Bay Ltd