OTC Medication Information: XtraCare Oatmeal Daily Moisturizing 8 Oz

XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ- dimethicone lotion
Rejoice International 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.

Active ingredient

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

  • Help prevent and temporarily protects 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.

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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

Keep out of reach of children.

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

Directions a pply liberally as often as needed.

Other information Store at room temperature.

Water, Petrolatum, Isopropyl Myristate, Glycerin, Glyceryl Stearate, Propylene Glycol, PEG-100 Stearate, Polyacrylamide, Cetyl Alcohol, Avena Sativa (Oat) Kernel Extract, Fragrance, DMDM Hydantoin, Stearyl Alcohol, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Methylparaben, Propylparaben.

Questions/comments? 1-855-345-5575

Tube Label
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XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-139
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 1.3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
STEARYL ALCOHOL
METHYLPARABEN
GLYCERYL MONOSTEARATE
DMDM HYDANTOIN
PETROLATUM
OAT
PEG-100 STEARATE
WATER
GLYCERIN
EDETATE DISODIUM
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
ISOPROPYL MYRISTATE
PROPYLPARABEN
PROPYLENE GLYCOL
CETYL ALCOHOL
LAURETH-7
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57337-139-01 227 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/19/2021
Labeler — Rejoice International Inc. (078741245)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Technology Co., Ltd. 529287434 manufacture (57337-139)

Revised: 04/2021 Rejoice International Inc.

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.

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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