OATMEAL- dimethicone lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Better Living Brands, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
skin protectant - helps prevent and temporarily protects chafed, chapped, or cracked skin - helps protect from the drying effects of wind and cold weather - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days - deep or puncture wounds - animal bites - serious burns
Authorization status:
OTC monograph final
Authorization number:
21130-898-32, 21130-898-44

OATMEAL- dimethicone lotion

Better Living Brands, LLC

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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signature care 619.003/619AC rev 2

active ingredient

Dimethicone 1.3%

Purpos e

skin protectant

Us es

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

helps protect from the drying effects 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

symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds

animal bites

serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as necessary

Inactive ingredients

water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena

sativa (oat) kernel flour, benzyl alcohol, sodium chloride

adverse reaction

*This product is not manufactured or distributed by Johnson & Johnson Consumer Prodcuts Company,

distributor of Aveeno Active Naturals Daily

Moisturizing Lotion

This non-greasy, fast absorbing formula relieves dryness and can be used every day for hands and body.

It is non-comedogenic and contains no

added fragrance

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929 www.betterlivingbrandsLLC.com

619.003/619AC rev 2

principal display panel

Signature

CARE

Quality Guaranteed

Daily

Moisturizing

LOTION

SKIN PROTECTANT

PROTECTS & RELIEVES DRY SKIN

COMPARE TO AVEENO DAILY MOISTURIZING LOTION

fragrance-free

non-comedogenic

dermatologist tested

12 FL OZ (354 mL)

OATMEAL

dimethicone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21130 -8 9 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Better Living Brands, LLC

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

13 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PETRO LATUM (UNII: 4T6 H12BN9 U)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

o a tmea l (UNII: 8 PI54V6 6 3Y)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:21130 -8 9 8 -

354 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 9 /20 16

2

NDC:21130 -8 9 8 -

532 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 9 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 3/0 9 /20 16

Labeler -

Better Living Brands, LLC (009137209)

Registrant -

Vi Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi Jo n

79 0 752542

ma nufa c ture (21130 -8 9 8 )

Revised: 6/2020

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