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NDC 36800-0619-44 Daily Moisturizing 13.13 mg/mL Details

Daily Moisturizing 13.13 mg/mL

Daily Moisturizing is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo Associates LLC. The primary component is DIMETHICONE.

Product Information

NDC	36800-0619
Product ID	36800-619_1e956cac-469b-4a06-8b06-530d3ef3298b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Daily Moisturizing
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	13.13
Active Ingredient Units	mg/mL
Substance Name	DIMETHICONE
Labeler Name	TopCo Associates LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0619-44 (36800061944)

Pricing Information	N/A
NDC Package Code	36800-619-44
Billing NDC	36800061944
Package	532 mL in 1 BOTTLE, PUMP (36800-619-44)
Marketing Start Date	2010-09-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 47e54eee-70e0-4bfa-ae77-d61a6560a9e1 Details

Active ingredient

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

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

Warnings

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

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 not manufactured or distributed by Johnon & Johnson Consumer Products Company, distributor of Aveno Daily Moisturizing Lotion

Made in the USA with US and foreign components.

DIST. BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139 [email protected]

www.topccarebrand.com

principal display panel

TOPCARE beauty

DAILY MOISTURIZING LOTION

Dimethicone Skin Protectant

Compare to AVEENO

With natural colloidal oatmeal

Dermatologist tested

Fragrance Free

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

DAILY MOISTURIZING

dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-619
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
Packaging
1	NDC:36800-619-40	354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/03/2010
2	NDC:36800-619-44	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/03/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/03/2010

Labeler - TopCo Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-619)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-619)

Revised: 3/2022

Document Id: 1e956cac-469b-4a06-8b06-530d3ef3298b

Set id: 47e54eee-70e0-4bfa-ae77-d61a6560a9e1

Version: 12

Effective Time: 20220321