RESURFIX PLUS- petrolatum ointment

Resurfix Plus by

Drug Labeling and Warnings

Resurfix Plus by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Petrolatum U.S.P

Purpose

Skin protectant

Uses

• A unique dressing formulated to aid in the Skin Barrier healing process. Also provides protection and helps heal stressed skin conditions such as chapped, dry and windburned skin.

Warnings

• Not to be applied over puncture wounds, infections, or lacerations.
• If condition worsens or does not improve within 7 days, contact a physician.

• Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

• For external use only, not to be swallowed.
• Avoid contact with eyes.

Directions

• Apply as directed by your physician.

Inactive ingredients

Allantoin, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract, Ceramide 2, Ceramide-3, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Glycine Soja (Soybean) Seed Extract, Lanolin Alcohol, Mineral Oil, Palmitoyl Oligopeptide, Panthenol, PEG-10 Rapeseed Sterol, Phospholipids, Saccharomyces Lysate Extract, Sorbitan Isostearate, Squalane, Tocopheryl Acetate, Tribehenin, Yucca Glauca Root Extract, Water.

PRINCIPAL DISPLAY PANEL - 100 g Tube Label

REPLENiX®

RESURFIX+SKIN BARRIER
HEALING OINTMENT
SKIN PROTECTANT

Post Aesthetic Post Procedure Post Treatment
Ceramide 2 & 3 LYCD
Green Tea Extract Squalane NF
Panthenol Vitamin E Allantoin
Petrolatum USP

Net wt. 3.5 oz. (100 g.)
Topix Pharmaceuticals, Inc. N. Amityville, NY 11701

INGREDIENTS AND APPEARANCE

RESURFIX PLUS 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-884
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	86 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Allantoin (UNII: 344S277G0Z)
Benzyl Alcohol (UNII: LKG8494WBH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
Ceramide Ng (UNII: C04977SRJ5)
Ceramide Np (UNII: 4370DF050B)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Ethylhexyl Palmitate (UNII: 2865993309)
Soybean (UNII: L7HT8F1ZOD)
Lanolin Alcohols (UNII: 884C3FA9HE)
Mineral Oil (UNII: T5L8T28FGP)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
Panthenol (UNII: WV9CM0O67Z)
PEG-10 Rapeseed Sterol (UNII: 258O76T85M)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
Saccharomyces Lysate (UNII: R85W246Z1C)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Squalane (UNII: GW89575KF9)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tribehenin (UNII: 8OC9U7TQZ0)
Yucca Glauca Root (UNII: 1A15YBH7N1)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-884-03	100 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/01/2000

Labeler - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-884)