SPL v1
SPL
SPL Set ID 21a6a7f5-411b-4b79-a415-29dd77a518e2
Route
TOPICAL
Published
Effective Date 2021-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Butylene Glycol 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-04-01

Description

Salicylic Acid 0.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid 0.5%

Uses

■ Helps improve acne problem.

Warnings

For external use only.

1. If there is any red spot, swallowing or itching by direct sunlight or if there is any other adverse effect during or after cosmetics use, consult with a doctor.

2. Refrain from using on the injured area.

3. Precaution for storage and handling.

a) Keep out of reach of children.

b) Keep away from direct sunlight.

Directions

■ After cleansing, take out an adequate amount on a hand, gently apply then dab to help the skin absorb.

Active Ingredient

Salicylic Acid 0.5%

Inactive Ingredients

WATER, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, GLYCERIN, SODIUM CITRATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, POLYGLYCERYL-10 LAURATE, POLYGLYCERYL-4 LAURATE, DIPROPYLENE GLYCOL, LACTIC ACID, GLYCOLIC ACID, HYDROLYZED GLYCOSAMINOGLYCANS, CAPRYLOYL SALICYLIC ACID, ZINC PCA, CITRIC ACID, SODIUM GLUCONATE, SUCCINIC ACID, LUCONOLACTONE, SODIUM CHLORIDE, SALIX ALBA (WILLOW) BARK EXTRACT, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, SODIUM HYALURONATE, ROSA CANINA FRUIT EXTRACT

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

■ Helps improve acne problem.

Purpose (PURPOSE)

Acne treatment

Warnings (WARNINGS)

For external use only.

1. If there is any red spot, swallowing or itching by direct sunlight or if there is any other adverse effect during or after cosmetics use, consult with a doctor.

2. Refrain from using on the injured area.

3. Precaution for storage and handling.

a) Keep out of reach of children.

b) Keep away from direct sunlight.

Directions

■ After cleansing, take out an adequate amount on a hand, gently apply then dab to help the skin absorb.

Active Ingredient (ACTIVE INGREDIENT)

Salicylic Acid 0.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, GLYCERIN, SODIUM CITRATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, POLYGLYCERYL-10 LAURATE, POLYGLYCERYL-4 LAURATE, DIPROPYLENE GLYCOL, LACTIC ACID, GLYCOLIC ACID, HYDROLYZED GLYCOSAMINOGLYCANS, CAPRYLOYL SALICYLIC ACID, ZINC PCA, CITRIC ACID, SODIUM GLUCONATE, SUCCINIC ACID, LUCONOLACTONE, SODIUM CHLORIDE, SALIX ALBA (WILLOW) BARK EXTRACT, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, SODIUM HYALURONATE, ROSA CANINA FRUIT EXTRACT

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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