PERIGUARD- otc skin protectant drug products ointment

PERIGUARD by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PERIGUARD 
otc skin protectant drug products ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	49.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-205-04	100 g in 1 TUBE; Type 0: Not a Combination Product	04/18/2011
2	NDC: 61924-205-07	198 g in 1 TUBE; Type 0: Not a Combination Product	04/18/2011
3	NDC: 61924-205-05	5 g in 1 PACKET; Type 0: Not a Combination Product	04/18/2011
4	NDC: 61924-205-15	15 g in 1 PACKET; Type 0: Not a Combination Product	04/18/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/18/2011

Labeler - DermaRite Industries, LLC (883925562)