RE/COVER KIT- colloidal oatmeal kit

Re/Cover kit by

Drug Labeling and Warnings

Re/Cover kit by is a Otc medication manufactured, distributed, or labeled by KAO USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

MOISTURE PATCH INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

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

• Serum helps to shorten eczema flare ups and relieve the itch
• Dermatologist Tested
• Steroid Free

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

INGREDIENTS AND APPEARANCE

RE/COVER KIT 
colloidal oatmeal kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-901

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-901-03	1 in 1 KIT; Type 0: Not a Combination Product	08/21/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		9 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	08/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/21/2023

Labeler - KAO USA (004251617)