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

PRINCIPAL DISPLAY PANEL - 100 g Tube Label

RESURFIX PLUS
petrolatum ointment

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M016	01/01/2000

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

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

Name	Address	ID/FEI	Business Operations
Establishment
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-884)