82767-002-04

82767-002-04
SPL v3
SPL
SPL Set ID e94a3d17-564f-3e64-e053-2995a90aa402
Route
TOPICAL
Published
Effective Date 2023-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Dimethicone/diene Dimethicone Crosspolymer Polyglycerin-6 Green Tea Leaf Phenoxyethanol Cetostearyl Alcohol Almond Oil Cetyl Alcohol Shea Butter Xanthan Gum Propylene Glycol Laureth-7 Glycerin Caprylyl Glycol Edetate Disodium .alpha.-tocopherol Acetate C13-14 Isoparaffin Hexylene Glycol Limonene, (+)- Aloe Vera Leaf Tea Tree Oil Medium-chain Triglycerides White Wax Glyceryl Stearate/peg-100 Stearate Sodium Hydroxide Rosemary Peppermint Oil .alpha.-hexylcinnamaldehyde Linalool, (+/-)- Benzyl Salicylate Benzyl Alcohol Citral Water Salix Alba Bark

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-22

Description

Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only.

Do not use on children under 12 years of age unless directed by a doctor.

Description

Salicylic Acid 2%

Use:

For the treatment of acne.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and consult a doctor if

Condition worsens or does not improve with regular use of this product as directed.

Section 50567-7

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.

Section 51727-6

Aqua, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Glycerin, Polyglyceryl-6 Palmitate/Succinate, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Organic Butyrospermum Parkii (Shea) Butter, Dimethicone, Dimethicone Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Parfum, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Salix Alba Bark Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hexyl Cinnamal, D-Limonene, Linalool, Benzyl Salicylate, Benzyl Alcohol, Citral.

Section 53413-1

Call (1-877-737-6267)

Section 53414-9

If pregnant or breast-feeding Consult a health care professional before use

Section 55105-1

Purpose: Acne treatment

Section 55106-9

Salicylic Acid 2%

Section 60561-8

See on the top of the tube for lot number and expiration date.

Protect the product in this container from excessive heat and direct sun.

Directions:

Clean the skin thoroughly before applying product.

Cover the entire affected area with a thin layer one to three times daily.

Because excess drying of the skin may occur, start with one application daily, then gradually increase to two or 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.

Butt & Thighs Acne Treatment Cream 4oz (label Box)


Structured Label Content

Use: (USE:)

For the treatment of acne.

Warnings and Precautions (34071-1)

For external use only.

Do not use on children under 12 years of age unless directed by a doctor.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and consult a doctor if

Condition worsens or does not improve with regular use of this product as directed.

Section 50567-7 (50567-7)

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.

Section 51727-6 (51727-6)

Aqua, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Glycerin, Polyglyceryl-6 Palmitate/Succinate, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Organic Butyrospermum Parkii (Shea) Butter, Dimethicone, Dimethicone Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Parfum, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Salix Alba Bark Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hexyl Cinnamal, D-Limonene, Linalool, Benzyl Salicylate, Benzyl Alcohol, Citral.

Section 53413-1 (53413-1)

Call (1-877-737-6267)

Section 53414-9 (53414-9)

If pregnant or breast-feeding Consult a health care professional before use

Section 55105-1 (55105-1)

Purpose: Acne treatment

Section 55106-9 (55106-9)

Salicylic Acid 2%

Section 60561-8 (60561-8)

See on the top of the tube for lot number and expiration date.

Protect the product in this container from excessive heat and direct sun.

Directions: (DIRECTIONS:)

Clean the skin thoroughly before applying product.

Cover the entire affected area with a thin layer one to three times daily.

Because excess drying of the skin may occur, start with one application daily, then gradually increase to two or 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.

Butt & Thighs Acne Treatment Cream 4oz (label Box) (BUTT & THIGHS ACNE TREATMENT CREAM 4oz (Label - Box))


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