OTC Medication Information: Daily Moisturizing – Oatmeal

DAILY MOISTURIZING — OATMEAL- dimethicone lotion
Greenbrier International

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.

Active Ingredient Purpose

Dimethicone 1/3% …… Skin Protectant

XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion

dimethicone skin protectant

with soothing oat essence

To Protect & Relieve Dry Skin

12 fl oz (354 mL)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Use  help prevent and temporarily protets chafed, chapped, or cracked skin.

Warnings  For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

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.

Directions  apply liberally as often as needed.

Other information  Store at room temperature.

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

Inactive Ingredients  water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.

label
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DAILY MOISTURIZING — OATMEAL
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0055
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 3 g in 227 g
Inactive Ingredients
Ingredient Name Strength
WATER
PETROLATUM
ISOPROPYL MYRISTATE
GLYCERIN
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
PEG-100 STEARATE
POLYACRYLAMIDE (1500 MW)
CETYL ALCOHOL
OAT
DMDM HYDANTOIN
STEARYL ALCOHOL
C13-14 ISOPARAFFIN
LAURETH-7
EDETATE DISODIUM
METHYLPARABEN
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33992-0055-2 227 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 05/19/2014
Labeler — Greenbrier International (610322518)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp 529287434 manufacture (33992-0055)

Revised: 01/2019 Greenbrier International

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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