REMEDY SKIN PROTECTANT- white petrolatum paste 
Medline Industries, LP

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.

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302 Remedy Essentials Barrier

Active ingredient

Petrolatum 59%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

Do not use on

  • deep or puncture wounds
  • animal bites
  • 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

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aluminum Stearates, Beeswax, Benzethonium Chloride, Chloroxylenol, Cholecalciferol, Dicocoyl Pentaerythrityl Distearyl Citrate, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate, Sorbitan Sesquioleate, Stearic Acid, Tocopherol, Water, Zea Mays (Corn) Oil, Zinc Oxide

Package/Label Principal Display Panel

NDC 53329-302-14

Medline

REMEDY®

Essentials

Barrier Skin Protectant Ointment

Protects skin from prolonged exposure to moisture

CHG Compatible

FRAGRANCE FREE

Hypoallergenic

For All Ages

Net Wt. 2 oz (57 g)

label

REMEDY SKIN PROTECTANT 
white petrolatum paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM STEARATES (UNII: O4D7U3B46U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
PENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-302-1457 g in 1 TUBE; Type 0: Not a Combination Product11/06/2013
2NDC:53329-302-41169.5 g in 1 TUBE; Type 0: Not a Combination Product11/06/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01611/06/2013
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efcfa488-6020-fcbd-e053-2995a90ad540
Set id: 0ec52309-642f-4667-9199-6711190fa1d4
Version: 5
Effective Time: 20221214
 
Medline Industries, LP