RestoreZ by Sage Products LLC RestoreZ

RestoreZ by

Drug Labeling and Warnings

RestoreZ by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RESTOREZ- zinc oxide cloth 
Sage Products LLC

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RestoreZ

Active Ingredient

Zinc Oxide 15%

Purpose

Skin protectant

Uses

• helps treat and prevent contact dermatitis presenting as incontinence associated dermatitis (IAD) or as moisture associated skin damage (MASD)
• temporarily protects against minor skin irritation and minor skin damage associated with IAD or MASD
• temporarily helps protect against wetness (excess moisture)

Warnings

• For external use only
• Do not flush

When using this product

• do not get into eyes

Keep out of reach of children

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

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

• If seal is compromised, discard package immediately
• remove wet and soiled garments per hospital protocol
• cleanse soiled area per hospital protocol
• use tear notch to open package
• remove 1 cloth from package and unfold
• using first unfolded cloth, apply product across affected area
• If needed, use the second cloth to apply additional product across affected area. If second cloth is not used, discard it.
•  discard after use per hospital protocols and local regulations –DO NOT FLUSH
• continue using product if prolonged exposure to wetness is anticipated

Inactive Ingredients

Aloe vera, beeswax, cetearyl ethylhexanoate, corn starch, dicaprylyl carbonate, dimethicone, ethylhexylglycerin, glycerin, hydroxyethylcellulose, isopropyl myristate, isopropyl palmitate, lanolin, phenoxyethanol, propylene glycol, tri(polyglyceryl- 3/lauryl) hydrogenated trilinoleate, water
cloths: polyester (PET) fiber, polyethylene film

Questions or Comments

847-829-5419
(Monday to Friday 8 AM-5 PM CST)

RestoreZ
Zinc oxide (15%) cloths

RESTOREZ 
zinc oxide cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-916
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%) (UNII: GSS77345H7)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LANOLIN (UNII: 7EV65EAW6H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-916-20	2 in 1 PACKAGE	09/08/2023
1		0.15 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/10/2023	10/20/2023

Labeler - Sage Products LLC (054326178)

Revised: 3/2024

Document Id: 12ee95f6-e4aa-2270-e063-6294a90a5b25

34390-5

Set id: 70b2b3c2-f0fd-40f0-b6f2-5f8522aca161

Version: 6

Effective Time: 20240305