XCELLDERMA- wound cream cream

Xcellderma by

Drug Labeling and Warnings

Xcellderma by is a Otc medication manufactured, distributed, or labeled by Regenerex Pharma INC, Regenerex Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Clean the affected area. Apply Xcellderma. Reapply after 24 hours.

WARNINGS

Warnings: External use only. Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, stop use and consult a doctor.

INDICATIONS & USAGE

Indications: To cover and protect abrasions, skin tears, pressure ulcers and minor burns.

INACTIVE INGREDIENT

Inactive ingredients: Polyethylene Glycol 4000, Polyethylene Glycol 400, Water, Citric Acid, Potassium Citrate, Benzoic Acid, Rubidium Chloride, Calcium Chloride.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

To serve as a wound protectant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XCELLDERMA 
wound cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84076-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE ANHYDROUS (UNII: OFM21057LP)
RUBIDIUM CHLORIDE (UNII: N3SHC5273S)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
ZINC CHLORIDE (UNII: 86Q357L16B)	0.002 g  in 1 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84076-111-01	30 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/01/2024

Labeler - Regenerex Pharma INC (119109997)

Establishment
Name	Address	ID/FEI	Business Operations
Regenerex Pharma Inc		119109997	manufacture(84076-111)