Drying Lotion

Drying Lotion
SPL v1
SPL
SPL Set ID 02e3dd2c-45d8-9419-e063-6294a90a2206
Route
TOPICAL
Published
Effective Date 2023-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (1.4 g)
Inactive Ingredients
Magnesium Aluminum Silicate Zinc Oxide Salicylic Acid Camphor (synthetic) Isopropyl Alcohol Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-14

Description

Active Ingredient Sulfur Colloidal (10%)


Medication Information

Warnings and Precautions

Warnings

For external use only

  • 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.
Indications and Usage

Uses

  • for the treatment of acne
  • healing and drying acne breakouts
  • helps clear acne pimples, blackheads or whiteheads and allows skin to heal
  • penetrates pores to control acne blemishes
  • helps keep skin clear of new acne pimples

Dosage and Administration

Directions

Do Not Shake

  • clean skin thoroughly before applying this product
  • carefully place wand or cotton swab into sediment at bottom and apply directly to the blemish
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed

    by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Description

Active Ingredient Sulfur Colloidal (10%)

Section 50565-1

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • excessive dryness or peeling occurs
Section 50567-7

When using this product

  • apply only to areas with acne
Section 50570-1

Do Not Use

  • on broken skin
  • on large areas of the skin
  • if pregnant or breast-feeding, ask a health professional before use.
Section 51727-6

Inactive ingredients

Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid,

Zinc Oxide.

Section 51945-4

BOTTLE LABEL ART SHOWN BELOW

Section 55105-1

Purpose

Topical Acne Treatment

Section 55106-9

Active Ingredient

Sulfur Colloidal (10%)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the treatment of acne
  • healing and drying acne breakouts
  • helps clear acne pimples, blackheads or whiteheads and allows skin to heal
  • penetrates pores to control acne blemishes
  • helps keep skin clear of new acne pimples

Dosage and Administration (34068-7)

Directions

Do Not Shake

  • clean skin thoroughly before applying this product
  • carefully place wand or cotton swab into sediment at bottom and apply directly to the blemish
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed

    by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Warnings and Precautions (34071-1)

Warnings

For external use only

  • 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.
Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • excessive dryness or peeling occurs
Section 50567-7 (50567-7)

When using this product

  • apply only to areas with acne
Section 50570-1 (50570-1)

Do Not Use

  • on broken skin
  • on large areas of the skin
  • if pregnant or breast-feeding, ask a health professional before use.
Section 51727-6 (51727-6)

Inactive ingredients

Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid,

Zinc Oxide.

Section 51945-4 (51945-4)

BOTTLE LABEL ART SHOWN BELOW

Section 55105-1 (55105-1)

Purpose

Topical Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Sulfur Colloidal (10%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)