ACNE PHAGE SERUM- encapsulated salicylic acid cream

Acne Phage Serum by

Drug Labeling and Warnings

Acne Phage Serum by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient : Encapsulated Salicylic Acid 0.5%

PURPOSE

Purpose: Acen Treatment

INDICATIONS & USAGE

Uses:

For the treatment of acne
Help clear up acne blemishes and allows skin to heal

WARNINGS

Warning: For external use only

DO NOT USE

If you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

WHEN USING

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

STOP USE

If irritation occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

Other information:

Store at room temperatures
Avoid high temperature
Protect from freezing
Keep away from flame, fire and heat

DOSAGE & ADMINISTRATION

Direction:

Clean the skin thoroughly before applying product
Cover the entire affected area with the thin layer one to three time daily
Because excessive drying of the skin may ocure, start with one application daily, then gradually increases to two three time daily or as directed by a doctor
If bothersome dryness or peeling occurs, reduce application to once a day or every other day

INACTIVE INGREDIENT

Inactive ingredient: Water, Glycerin, Butylene Glycol, Hydroxyethylcellulose, C.Acnes Bacteriophage, Sodium Phosphate, Sodium Chloride, Phenoxyethanol, Polydextrose, Sclerotium Gum, Niacinamide, Magnesium Sulfate, Caffeine, Calcium Chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE PHAGE SERUM 
encapsulated salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4268
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYDEXTROSE (UNII: VH2XOU12IE)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BACTERIOPHAGE PHI X174 (UNII: E551GJY38X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
CAFFEINE (UNII: 3G6A5W338E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4268-2	1 in 1 CARTON	09/26/2024
1	NDC: 62742-4268-1	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/26/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4268)