DRUG LISTING:PERIGUARD OINTMENT

DRUG LISTING:PERIGUARD OINTMENT

Drug Labeling and Warnings

Drug Details

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PERIGUARD- otc skin protectant drug products ointment 
DermaRite Industries, LLC

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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DRUG LISTING:PERIGUARD OINTMENT

Active Ingredient:

Petrolatum 49.9%

Purpose:

Skin Protectant

Uses:

A moisture barrier that prevents and helps treat skin irritation from urine, feces, perspiration, conditions associated with diaper rash from incontinence.

Warnings:

  • For external use only.
  • Avoid contact with eyes.In case of contact, flush thoroughly with water.
  • Stop use and ask doctor if condition worsens or does not improve within 7 days.
  • In case of accidental ingestion contact a physician or Poison Control Center right away.

Warnings:

  • Keep out of reach of children. If swallowed, contact a physician or Poison Control Center right away.

Directions:

Cleanse skin gently with a mild cleanser. Pat dry or allow to dry. Apply a thin layer of ointment to the affected area as necessary, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other Information:

Store at room temperature (59 o- 86 oF)

Inactive Ingredients:

Water, Lanolin, Mineral Oil, Paraffin, Zinc Oxide, Sorbitan Sequioleate, Beeswax, Propylene Glycol, Imidazolidinyl Urea, Methylparaben,propylparaben, Aluminum Stearate, Phenoxyethanol, Fragrance, Chloroxylenol,Cholecalciferol, Retinyl Palmitate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Zea Mays (corn) Oil

Questions?

Call 1-800-37-6296

Periguard Package Label Principal Display Panel

PeriGuard

PERIGUARD 
otc skin protectant drug products ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61924-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM49.9 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM STEARATES (UNII: O4D7U3B46U)  
WHITE WAX (UNII: 7G1J5DA97F)  
CORN OIL (UNII: 8470G57WFM)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61924-205-04100 g in 1 TUBE; Type 0: Not a Combination Product04/18/2011
2NDC: 61924-205-07198 g in 1 TUBE; Type 0: Not a Combination Product04/18/2011
3NDC: 61924-205-055 g in 1 PACKET; Type 0: Not a Combination Product04/18/2011
4NDC: 61924-205-1515 g in 1 PACKET; Type 0: Not a Combination Product04/18/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/18/2011
Labeler - DermaRite Industries, LLC (883925562)

Revised: 12/2018
 
DermaRite Industries, LLC


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