SPL v1
SPL
SPL Set ID 3a1bdfc9-8c0e-4b79-e063-6394a90a2c42
Route
TOPICAL
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera Venom (2 g) Salicylic Acid (17 g)
Inactive Ingredients
Allantoin Chlorhexidine Acetate Hydroxyethylcellulose Urea Glycerin Phenoxyethanol Aqua Lactic Acid Sophora Flavescens Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

Bee Venom 2% Salicylic Acid 17%


Medication Information

Warnings and Precautions

WarningsFor external use only. Flammable-keep away from fireand flames. Do not apply to irritated skin or any areasthat are infected or reddened. Avoid use on moles,birthmarks,warts with hair,genital warts, or warts on theface or mucous membranes.Not recommended forindividuals with diabetes or poor blood circulation.

Indications and Usage

Direction

1.Wash the area affected by cors or warts with warmwater.2.Remove the inner plug from the bottle. Instail the brushinto the bottle cap. press the brush tightly, and securelytighten the cap on the bottle.3. Apply the solution directly to the wart, corm, or callus.Use for an extended period if the wart or corn is large.

Dosage and Administration

Apply the solution directly to the wart, corm, or callus.Use for an extended period if the wart or corn is large.

Description

Bee Venom 2% Salicylic Acid 17%

Section 50565-1

Please keep the product out of reach of children. If accidentally ingested, please call the emergency center immediately.

Section 50566-9

Stop use and ask a doctor ifeskin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rasheiregular heartbeat or palpitations occureyou get symptoms of nicotine overdose such as nausea.vomiting,dizziness, weakness and rapid heartbeateyou have symptoms of an allergic reaction (such asdifficulty breathing or rash)

Section 51727-6

AQUA

GLYCERIN

LACTIC ACID

UREA

Chlorhexidine Acetate

SOPHORA FLAVESCENS EXTRACT

HYDROXYETHYLCELLULOSE

ALLANTOIN

PHENOXYETHANOL

Section 51945-4

Section 55105-1

wart, corn and callus remover

Section 55106-9

Bee Venom 2%

Salicylic Acid 17%


Structured Label Content

Indications and Usage (34067-9)

Direction

1.Wash the area affected by cors or warts with warmwater.2.Remove the inner plug from the bottle. Instail the brushinto the bottle cap. press the brush tightly, and securelytighten the cap on the bottle.3. Apply the solution directly to the wart, corm, or callus.Use for an extended period if the wart or corn is large.

Dosage and Administration (34068-7)

Apply the solution directly to the wart, corm, or callus.Use for an extended period if the wart or corn is large.

Warnings and Precautions (34071-1)

WarningsFor external use only. Flammable-keep away from fireand flames. Do not apply to irritated skin or any areasthat are infected or reddened. Avoid use on moles,birthmarks,warts with hair,genital warts, or warts on theface or mucous membranes.Not recommended forindividuals with diabetes or poor blood circulation.

Section 50565-1 (50565-1)

Please keep the product out of reach of children. If accidentally ingested, please call the emergency center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifeskin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rasheiregular heartbeat or palpitations occureyou get symptoms of nicotine overdose such as nausea.vomiting,dizziness, weakness and rapid heartbeateyou have symptoms of an allergic reaction (such asdifficulty breathing or rash)

Section 51727-6 (51727-6)

AQUA

GLYCERIN

LACTIC ACID

UREA

Chlorhexidine Acetate

SOPHORA FLAVESCENS EXTRACT

HYDROXYETHYLCELLULOSE

ALLANTOIN

PHENOXYETHANOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

wart, corn and callus remover

Section 55106-9 (55106-9)

Bee Venom 2%

Salicylic Acid 17%


Advanced Ingredient Data


Raw Label Data

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