Acne All-over Body Spray Ndc 71714-005-01

Acne All-over Body Spray Ndc 71714-005-01
SPL v1
SPL
SPL Set ID 46a4f734-1f73-1142-e063-6294a90a494a
Route
TOPICAL
Published
Effective Date 2025-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Propanediol Niacinamide Sodium Hydroxide Water Phenoxyethanol T-butyl Alcohol Alcohol Ethylhexylglycerin Saccharide Isomerate Citric Acid Denatonium Benzoate Sodium Citrate Aloe Barbadensis Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-26

Description

Keep out of reach of children ■ if swallowed, get medical help or contact a Poison Control Center right away


Medication Information

Warnings and Precautions

Warnings

■ For External Use Only

When using this product ■ 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.

■ Avoid spraying in eyes ■ Contents under pressure.

Do not puncture or incinerate. Do not store at a

temperature above 120°F11(49°C) or below 40°F11(5°C}.

Do not use if you ■ have very sensitive

skin ■ are sensitive to salicylic acid



Stop use and ask a doctor if irritation

becomes severe



Keep out of reach of children

■ if swallowed, get medical help or contact

a Poison Control Center right away

Indications and Usage

Uses ■ For the management of acne

Dosage and Administration



Directions

■ clean the skin thouroughly before applying this product

■ cover the entire affected area with a thin layer one to three times daily

■ because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily, then gradually increase to 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

■ see the Best Use section for more information on how to use for optimal results.

Description

Keep out of reach of children ■ if swallowed, get medical help or contact a Poison Control Center right away

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 irritation

becomes severe.

Section 51727-6

Inactive Ingredients:

Water/Aqua/Eau, Propanediol, Alcohol Denat, Niacinamide, Phenoxyethanol, Saccharide Isomerate, Sodium Hydroxide, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, t-Butyl Alcohol, Citric Acid, Sodium Citrate, Denatonium Benzoate

Section 51945-4

Section 55105-1

Purpose.......Acne Treatment

Section 55106-9

Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

Uses ■ For the management of acne

Dosage and Administration (34068-7)



Directions

■ clean the skin thouroughly before applying this product

■ cover the entire affected area with a thin layer one to three times daily

■ because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily, then gradually increase to 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

■ see the Best Use section for more information on how to use for optimal results.

Warnings and Precautions (34071-1)

Warnings

■ For External Use Only

When using this product ■ 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.

■ Avoid spraying in eyes ■ Contents under pressure.

Do not puncture or incinerate. Do not store at a

temperature above 120°F11(49°C) or below 40°F11(5°C}.

Do not use if you ■ have very sensitive

skin ■ are sensitive to salicylic acid



Stop use and ask a doctor if irritation

becomes severe



Keep out of reach of children

■ if swallowed, get medical help or contact

a Poison Control Center right away

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 irritation

becomes severe.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water/Aqua/Eau, Propanediol, Alcohol Denat, Niacinamide, Phenoxyethanol, Saccharide Isomerate, Sodium Hydroxide, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, t-Butyl Alcohol, Citric Acid, Sodium Citrate, Denatonium Benzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose.......Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)