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Remedy with Phytoplex Z-Guard

Dosage form: paste
Ingredients: PETROLATUM 57g in 100g
Labeler: Medline Industries Inc.
NDC Code: 53329-138

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.

Drug Facts

Active ingredient

White Petrolatum 57%

Purpose

Skin Protectant

Uses
  • Helps treat and prevent diaper rash caused from wetness, urine, and/or stool
  • Temporarily protects and helps relieve chapped or cracked skin
  • Temporarily protects minor cuts, scrapes, and burns

Warnings

For external use only.

Do not use
  • on deep or puncture wounds
  • on animal bites
  • on serious burns

When using this product
  • do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms last for 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 right away.

Directions
  • Cleanse with Remedy cleanser and pat dry
  • Apply a protective layer of Z-Guard to raw, oozing, denuded, partial thickness area of skin loss
  • Apply daily as needed
  • Remove gently with Remedy cleanser.

Other information
  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

Allantoin, Aluminum Starch Octenylsuccinate, Aphanizomemnon Flos-Aquae (Algae) Extract, Beeswax, Calophyllum Tacamahaca Seed Oil, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Glycine Soja (Soybean) Oil, Isopropyl Myristate, Methyldihydrojasmonate, Olea Europaea (Olive) Fruit Oil, Phospholipids, Theobroma Cacao (Cocoa) Seed Butter, Tocophersolan, TocopheryI Acetate, Vanilla Planifolia Fruit Extract, Zinc Oxide

Package/Label Principal Display Panel

NDC 53329-138-44

REMEDY

WITH PHYTOPLEX

Z-GUARD

SKIN PROTECTANT

PASTE

Nourishes skin. Helps treat and prevent diaper rash, wet and cracked skin.

HYPOALLERGENIC

NON-SENSITIZING

Net Wt. 4 oz (113 g)

REMEDY WITH PHYTOPLEX Z-GUARD 
white petrolatum paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-138
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM57 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALUMINUM STARCH OCTENYLSUCCINATE 
YELLOW WAX 
CALOPHYLLUM TACAMAHACA SEED OIL 
GREEN TEA LEAF 
COCONUT OIL 
DIMETHICONE 
ETHYLENE BRASSYLATE 
CLOVE 
SOYBEAN OIL 
ISOPROPYL MYRISTATE 
METHYL DIHYDROJASMONATE (SYNTHETIC) 
OLIVE OIL 
LECITHIN, SOYBEAN 
COCOA BUTTER 
TOCOPHERSOLAN 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
VANILLA 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:53329-138-1459 g in 1 TUBE
2NDC:53329-138-44113 g in 1 TUBE
3NDC:53329-138-96144 PACKET in 1 BOX
3NDC:53329-138-165 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2011
Labeler - Medline Industries Inc. (025460908)

Revised: 05/2012
 
Medline Industries Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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