RENEW PERIPROTECT- skin protectant ointment

Renew Periprotect by

Drug Labeling and Warnings

Renew Periprotect by is a Otc medication manufactured, distributed, or labeled by DermaRite Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active Ingredients:

Zinc Oxide 12%

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

• Helps treat and prevent diaper rash.
• Protects minor skin irritation associated with

diaper rash and helps seal out wetness.

​Warnings:

• For external use only,
• Avoid contact with eyes, In case of contact, flush thoroughly with water.

Warnings:

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.

Warnings:

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

• Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
• Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information:

• Store at room temperature (59º-86ºF)
• You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Imidazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin Wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.

Questions?

Call 800-337-6296 Mon - Fri 9AM - 5PM EST.

Renew Periprotect Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

RENEW PERIPROTECT 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-435
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)
WATER (UNII: 059QF0KO0R)
N-(1,3,4-TRIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA (UNII: ENL2IA4WGW)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
BEE PROPOLIS EXTRACT (UNII: 6Y8XYV2NOF)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CORN OIL (UNII: 8470G57WFM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-435-04	114 g in 1 TUBE; Type 0: Not a Combination Product	10/18/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/18/2016

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries, LLC		883925562	manufacture(61924-435)