SPL v3
SPL
SPL Set ID 3dd69bcb-3743-eb01-e063-6394a90ab7e0
Route
TOPICAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicyloyl Phytosphingosine (10 mg) Gluconolactone (100 mg)
Inactive Ingredients
Butylene Glycol Caprylyl Glycol Sodium Hyaluronate Niacinamide Allantoin Biosaccharide Gum-1 Dipropylene Glycol Water Panthenol Hydroxyacetophenone Ethylhexylglycerin 1,2-hexanediol Betaine Phenoxyethanol Chlorphenesin Pentylene Glycol Sodium Citrate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-09-01

Description

Dosage and Administration For topical use only. Apply evenly to clean, dry skin at night, avoiding the eye and lip areas. Use 1–2 times per week or as directed by a skincare professional. Do not rinse off immediately; leave on overnight unless irritation occurs. Begin with less frequent use to assess tolerance, especially for sensitive skin. Always apply a broad-spectrum sunscreen during the day when using this product. Do not apply on broken, inflamed, or compromised skin.


Medication Information

Warnings and Precautions

For external use only.

Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water.

Do not apply to broken, irritated, or inflamed skin.

A mild tingling or redness may occur. If severe irritation develops, discontinue use and consult a healthcare professional.

Use sunscreen and limit sun exposure while using this product, as it may increase skin sensitivity to the sun.

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

Indications and Usage

Indications and Usage

  • KrX Aesthetics Biophase Molecular Night Peel (PHA/LHA) is indicated for topical use as an exfoliating treatment.
  • Helps gently resurface the skin to improve texture, clarity, and brightness.
  • Aids in the removal of dead skin cells while promoting a smoother, more radiant complexion.
  • Recommended for use at night as part of a skincare regimen.
  • Not intended for use on broken or inflamed skin.
Dosage and Administration

Dosage and Administration

  • For topical use only.
  • Apply evenly to clean, dry skin at night, avoiding the eye and lip areas.
  • Use 1–2 times per week or as directed by a skincare professional.
  • Do not rinse off immediately; leave on overnight unless irritation occurs.
  • Begin with less frequent use to assess tolerance, especially for sensitive skin.
  • Always apply a broad-spectrum sunscreen during the day when using this product.
  • Do not apply on broken, inflamed, or compromised skin.
Description

Dosage and Administration For topical use only. Apply evenly to clean, dry skin at night, avoiding the eye and lip areas. Use 1–2 times per week or as directed by a skincare professional. Do not rinse off immediately; leave on overnight unless irritation occurs. Begin with less frequent use to assess tolerance, especially for sensitive skin. Always apply a broad-spectrum sunscreen during the day when using this product. Do not apply on broken, inflamed, or compromised skin.

Section 50565-1

keep out of reach of children

Section 51727-6

Water

Butylene Glycol

Niacinamide

Panthenol

Dipropylene Glycol

Pentylene Glycol

Betaine

Sodium Citrate

Hydroxyacetophenone

Allantoin

Biosaccharide Gum-1

Sodium Hyaluronate

Ethylhexylglycerin

Caprylyl Glycol

1,2-Hexanediol

Phenoxyethanol

Chlorphenesin

Fragrance

Section 51945-4

Product labeling

Section 55105-1

Exfoliant / Skin Resurfacing

Brightening & Smoothing

Section 55106-9

Gluconolactone (PHA)

Salicyloyl Phytosphingosine (LHA)


Structured Label Content

Indications and Usage (34067-9)

Indications and Usage

  • KrX Aesthetics Biophase Molecular Night Peel (PHA/LHA) is indicated for topical use as an exfoliating treatment.
  • Helps gently resurface the skin to improve texture, clarity, and brightness.
  • Aids in the removal of dead skin cells while promoting a smoother, more radiant complexion.
  • Recommended for use at night as part of a skincare regimen.
  • Not intended for use on broken or inflamed skin.
Dosage and Administration (34068-7)

Dosage and Administration

  • For topical use only.
  • Apply evenly to clean, dry skin at night, avoiding the eye and lip areas.
  • Use 1–2 times per week or as directed by a skincare professional.
  • Do not rinse off immediately; leave on overnight unless irritation occurs.
  • Begin with less frequent use to assess tolerance, especially for sensitive skin.
  • Always apply a broad-spectrum sunscreen during the day when using this product.
  • Do not apply on broken, inflamed, or compromised skin.
Warnings and Precautions (34071-1)

For external use only.

Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water.

Do not apply to broken, irritated, or inflamed skin.

A mild tingling or redness may occur. If severe irritation develops, discontinue use and consult a healthcare professional.

Use sunscreen and limit sun exposure while using this product, as it may increase skin sensitivity to the sun.

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

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Water

Butylene Glycol

Niacinamide

Panthenol

Dipropylene Glycol

Pentylene Glycol

Betaine

Sodium Citrate

Hydroxyacetophenone

Allantoin

Biosaccharide Gum-1

Sodium Hyaluronate

Ethylhexylglycerin

Caprylyl Glycol

1,2-Hexanediol

Phenoxyethanol

Chlorphenesin

Fragrance

Section 51945-4 (51945-4)

Product labeling

Section 55105-1 (55105-1)

Exfoliant / Skin Resurfacing

Brightening & Smoothing

Section 55106-9 (55106-9)

Gluconolactone (PHA)

Salicyloyl Phytosphingosine (LHA)


Advanced Ingredient Data


Raw Label Data

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