SPL v1
SPL
SPL Set ID 33462cc7-af87-c1b5-e063-6294a90a2f83
Route
TOPICAL
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Paraffin Lanolin Phenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-21

Description

Salicyic Acid......................5.0%


Medication Information

Warnings and Precautions

·The liquid can get easily volatilized crystallized. tighten the cap after use.

·Avoid long-term contact with air while using.

·For external use only, don’t contact with eyes or swallow. Children should use it under the supervision of adults.

Indications and Usage

·To remove warts such as plantarvart.flat wart,common wart and corns,calluses.

·The plantar wart is recognized by it location only on the bottom of the foot it’s tenderness,and the interruption of the footprint pattern

Dosage and Administration

·Wash the affected area.

·May soak the wart in warm water for 5 minutes.

·Dry area thoroughly.

·Using the applicator(cotton swab)apply a layer of ointment to sufficiently cover each wart

·Allow it to fully absorb and cover it with a bandage as needed.

·Repeat this procedure once or twice daily as needed (until the wart is removed)for upto12weeks.

Description

Salicyic Acid......................5.0%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 50570-1

·On damaged skin cuts, abrasions, eczema sunburn.

·f you are allergic to any of the ingredients in this product.

·lf you are pregnant or breastfeeding

Section 51727-6

Shard paraffin, lanolin, phenol.

Section 51945-4

Section 55105-1

To remove warts such as plantar wart, flat wart, common wart and corns, calluses.

Section 55106-9

Salicyic Acid......................5.0%

Section 60561-8

Store between 68°F to 77°F(20°Cto25°C).

Protect from excessive heatabove 104°F(40°C)


Structured Label Content

Indications and Usage (34067-9)

·To remove warts such as plantarvart.flat wart,common wart and corns,calluses.

·The plantar wart is recognized by it location only on the bottom of the foot it’s tenderness,and the interruption of the footprint pattern

Dosage and Administration (34068-7)

·Wash the affected area.

·May soak the wart in warm water for 5 minutes.

·Dry area thoroughly.

·Using the applicator(cotton swab)apply a layer of ointment to sufficiently cover each wart

·Allow it to fully absorb and cover it with a bandage as needed.

·Repeat this procedure once or twice daily as needed (until the wart is removed)for upto12weeks.

Warnings and Precautions (34071-1)

·The liquid can get easily volatilized crystallized. tighten the cap after use.

·Avoid long-term contact with air while using.

·For external use only, don’t contact with eyes or swallow. Children should use it under the supervision of adults.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 50570-1 (50570-1)

·On damaged skin cuts, abrasions, eczema sunburn.

·f you are allergic to any of the ingredients in this product.

·lf you are pregnant or breastfeeding

Section 51727-6 (51727-6)

Shard paraffin, lanolin, phenol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

To remove warts such as plantar wart, flat wart, common wart and corns, calluses.

Section 55106-9 (55106-9)

Salicyic Acid......................5.0%

Section 60561-8 (60561-8)

Store between 68°F to 77°F(20°Cto25°C).

Protect from excessive heatabove 104°F(40°C)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)