RE/COVER KIT- colloidal oatmeal 
KAO USA

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Re/Cover

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema

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.

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

Directions

Apply to affected areas of skin as illustrated in the USAGE INSTRUCTIONS.

Other information

store at room temperature

Inactive ingredients

water, glycerin, cetearyl alcohol, petrolatum, stearic acid, C12-15 alkyl benzoate, dimethicone, aesculus hippocastanum (horse chestnut) seed extract, laureth-3, hydroxyacetophenone, ceteareth-20, allantoin, arginine, sodium hydroxide, carbomer, panthenol, tetrasodium glutamate diacetate, phenoxyethanol

Questions or comments?

1-800-309-1638

Moisture Patch Instructions

instructions

MOISTURE PATCH INGREDIENTS

Polyvinyl butyral, PEG-60 hydrogenated castor oil, butylene glycol

re/cover™

ECZEMA RELIEF SYSTEM

Fast-acting system quickly relieves the disruption and discomfort of eczema with a soothing serum and invisible protective moisture patch to help recover healthy-looking skin

+CALMING ECZEMA SERUM

COLLOIDAL OATMEAL SKIN PROTECTANT

+MOISTURE PATCHES

7 DAY SYSTEM

14 MOISTURE PATCHES

0.30 FL OZ (9 mL) CALMING ECZEMA SERUM

For additional information:

www.recoverskincare.com

or 1-800-309-1638

RE/COVER is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214

©2023

Patch: Made in Japan.

Serum: Made in USA of US & Imported Ingredients

label

RE/COVER KIT 
colloidal oatmeal kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-901
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10596-901-031 in 1 KIT; Type 0: Not a Combination Product08/21/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE, WITH APPLICATOR 1 mL
Part 1 of 1
RE/COVER SERUM 
colloidal oatmeal emulsion
Product Information
Item Code (Source)NDC:10596-902
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ARGININE (UNII: 94ZLA3W45F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LAURETH-3 (UNII: F32E4CB0UJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PANTHENOL (UNII: WV9CM0O67Z)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
19 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01608/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/21/2023
Labeler - KAO USA (004251617)

Revised: 8/2023
Document Id: 038909c9-2c5b-d40b-e063-6294a90a1ec6
Set id: 038909c9-2c5a-d40b-e063-6294a90a1ec6
Version: 1
Effective Time: 20230822
 
KAO USA