DAILY MOISTURIZING- dimethicone lotion
OnPoint, Inc

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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America's Choice 619

Claims

This unique formula helps preven and protect temporary relief of scaling and chapping associated with dry skin.

Active ingredient

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

helps prevent and temporarily protects chafed, chapped, cracked or windburned skin

Warnings

For external use only

Do not use on

deep or puncture wounds, infections, or lacerations. Consult a doctor.

When using this product

keep out of eyes

Stop use and ask a doctor if

condition worsens or does not improve within seven 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

disclaimer

This product is ot manufactured or distributed by Johnson + Johnson Consumer Products Company, distributor of Aveeno Active Naturals Daily Moisturizing Lotion.

Made in the USA with US and foreign components

Adverse Reactions

Distributed By OnPoint, Inc.,

2 Paragon Drive

Montvale, NJ 07645

619.03/619AC rev 2

principal display panel

AMERICA'S

CHOICE

DAILY

MOISTURIZING

LOTION

WITH NATURAL

COLLOIDAL OATMEAL

SKIN PROTECTANT

cOMPARE TO AVEENO

ACTIVE NATURALS

DAILY MOISTURIZING LOTION

12 FL OZ

(354 mL)

image description

DAILY MOISTURIZING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-619
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	13.13 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51143-619-40	354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/22/2011	05/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/22/2011	05/01/2020

Labeler - OnPoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(51143-619)

Revised: 5/2020

Document Id: 7f34723e-b698-4c97-b443-91677e29472f

Set id: 9fa68c5a-1cb4-4cad-b965-1387906e51da

Version: 6

Effective Time: 20200504

OnPoint, Inc