DAILY MOISTURIZING- dimethicone lotion 
American Sales Co

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

Claims

Care One

Oatmeal

Hand + Body

Daily Moisturizind Skin Protectant Lotion

active ingredient

Active ingredient

Dimethicone 1.3%

Purpose

Purpose

Skin protectant

Uses

Uses helps prevent and temporarily protects chafed, chapped, cracked or windburnd skin

Warnings

Warnings

For external use only

Do not use

Do not use on deep or puncture wounds, infections or lacerations. Consult a doctor

When using this product

When using this product keep out of eyes

Stop use

Stop use and ask a doctor if conditin worsens or does not improve within seven 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.

Directions

Directions apply liberally as often as necessary

Inactive ingredients

Inactive ingredients avena sativa (oat) kernel flour, benzyl aclohol, cetyl alcohol, distearyldimonium chloride, glycerin, isopropyl palmitate, petrolatum, sodium chloride, water

claim

2.2ex0em2.2ex0emMade in the USA with US and foreign components

Adverse Reaction

Distributed by

AMERICAN SALES CO.

4201 WALDEN AVE

LANCASTER, NY 14086

www.care1.info

Quality guaranteed or your money bac,

Principal display panel

CARE ONE

Oatmeal

Hand + Body

Daily Moisturizing

Skin Protectant Lotion

Relieves and Protects Dry Skin

Dermatologist Tested

Fragrance free

Hypoallergenic

12 FL OZ (354 mL)

image description

DAILY MOISTURIZING 
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-619
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.3 kg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
OATMEAL (UNII: 8PI54V663Y)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-619-40 354 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/15/2012
Labeler - American Sales Co (809183973)
Registrant - Vi Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi Jon 790752542 manufacture(41520-619)

Revised: 2/2013
Document Id: b3600254-6acf-4c02-a333-50d6401f4419
Set id: d0542550-36cd-4ac1-b640-414247d7c454
Version: 1
Effective Time: 20130211
 
American Sales Co