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SPL v1

SPL

SPL Set ID 9418140b-793c-ec75-e053-2995a90a7088

Route

TOPICAL

Published

Effective Date 2019-10-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (1.66 g)

Inactive Ingredients

Tea Tree Oil Green Tea Leaf Aloe Vera Leaf Polysaccharides

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-10-04

Description

SALICYLIC ACID, TEA TREE OIL

Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY.

AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN.

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOOCCURS.

Indications and Usage

USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS

Dosage and Administration

WASH FACE THOROUGHLY AND APPLY TO AFFECTED AREAS. USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS

Description

SALICYLIC ACID, TEA TREE OIL

Section 50565-1

KEEP OUT OF REACH FO CHILDREN

Section 51727-6

MEDIDERM CREAM, GREEN TEA EXTRACT, ALOE VERA, EMULTHIX

Section 51945-4

Section 55105-1

REMOVES PIMPLES

MINIMIZES PORES

ENHANCED WITH TEA TREE OIL AND ALOE VERA

Section 55106-9

SALICYLIC ACID, TEA TREE OIL

Structured Label Content

Indications and Usage (34067-9)

USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS

Dosage and Administration (34068-7)

WASH FACE THOROUGHLY AND APPLY TO AFFECTED AREAS. USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY.

AVOID CONTACT TO EYES.

KEEP OUT OF REACH OF CHILDREN.

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOOCCURS.

Section 50565-1 (50565-1)

KEEP OUT OF REACH FO CHILDREN

Section 51727-6 (51727-6)

MEDIDERM CREAM, GREEN TEA EXTRACT, ALOE VERA, EMULTHIX

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

REMOVES PIMPLES

MINIMIZES PORES

ENHANCED WITH TEA TREE OIL AND ALOE VERA

Section 55106-9 (55106-9)

SALICYLIC ACID, TEA TREE OIL

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "1.66", "strengthDenominator": "1.66", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF POLYSACCHARIDES", "unii": "W21O437517", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS", "34068-7": "WASH FACE THOROUGHLY AND APPLY TO AFFECTED AREAS. USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS", "34071-1": "FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOOCCURS.", "50565-1": "KEEP OUT OF REACH FO CHILDREN", "51727-6": "MEDIDERM CREAM, GREEN TEA EXTRACT, ALOE VERA, EMULTHIX", "55105-1": "REMOVES PIMPLES MINIMIZES PORES ENHANCED WITH TEA TREE OIL AND ALOE VERA", "55106-9": "SALICYLIC ACID, TEA TREE OIL"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:52.933822 · Updated: 2026-03-14T22:55:38.573608