Daily Moisturizing: Package Insert and Label Information

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.

Claims

Care One

Oatmeal

Hand + Body

Daily Moisturizind Skin Protectant Lotion

active ingredient

Dimethicone 1.3%

Purpose

Skin protectant

Uses

  • helps prevent and temporarily protects chafed, chapped, cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

Do not use

  • deep or puncture wounds
  • animal butes
  • serious burns

When using this product

keep out of eyes

Stop use aned 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 liberally as often as necessary

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride

claim

Made in the USA with US and foreign components

Adverse Reactions

Distributed by

AMERICAN SALES CO

4201 WALDEN AVE

LANCASTER, NY 14086

QUALITY GUARANTEED OR YOUR MONEY BACK.

619.003/AC rev 2

principal display panel

CAREONE

Oatmeal

Hand & Body

DailyMoisturizing

Skin Protectant Lotion

Relieves and Protects Dry Skin

Dermatologist Tested

Fragrance Free

Hypoalergenic

12 FL OZ (354 mL)

image description
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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 (DIMETHICONE) DIMETHICONE 13 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
glycerin
DISTEARYLDIMONIUM CHLORIDE
PETROLATUM
ISOPROPYL PALMITATE
CETYL ALCOHOL
OATMEAL
BENZYL ALCOHOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41520-619-40 354 mL in 1 BOTTLE, PUMP None
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 Operations
Vi Jon 790752542 manufacture (41520-619)

Revised: 07/2020 American Sales Co

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