Oars + Alps Anti-everything Face Moisturizer

Oars + Alps Anti-everything Face Moisturizer
SPL v1
SPL
SPL Set ID 36cb28f2-2620-4b88-811f-a2d6c1e22e79
Route
TOPICAL
Published
Effective Date 2024-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.0 g)
Inactive Ingredients
Water Cetyl Alcohol Dimethicone Medium-chain Triglycerides Glyceryl Stearate Citrate Ammonium Acryloyldimethyltaurate/vp Copolymer Squalane Dicaprylyl Carbonate Glycerin Phenoxyethanol Sodium Hydroxide Isopentyldiol Sodium Stearoyl Glutamate Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Cladonia Rangiferina Whole Ethylhexylglycerin Gluconolactone Trifolium Pratense Flower Hyaluronate Sodium Arctium Lappa Root Portulaca Oleracea Leaf Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-08

Description

Drug Facts Active Ingredients Salicylic Acid  1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use if you have very sensitive

skin or known allergy to aspirin

Slop use and ask a doctor if

excessive itching, dryness, redness,

burning, or swelling occurs or if these

symptoms persist

When using this product • Keep

away from eyes, lips, and other

mucous membranes. If contact occurs,

flush thoroughly with water.• Using

other topical acne medications at the

same time or immediately following

use of this product may increase

dryness or irritation of the skin. If this

occurs, only one medication should be

used unless directed by doctor.

Indications and Usage

Uses

• For the treatment of acne

• Reduces the number of acne pimples,

blackheads, whiteheads and allows

skin to heal

• Penetrates pores to clear most acne

blemishes

• Helps prevent new acne blemishes

from formlng

Dosage and Administration

Directions

• Squeeze 1-2 pumps on to fingertips.

Apply evenly on clean, dry skin at

night. Avoid eye area. Suggested use

in PM.

• At first, use every other day. Then

up to twice a day as tolerated

• Use sunscreen during the day while

using this product

• Because excessive drying of the skin

may occur, start with one application

daily, then gradually increase if needed

or as directed by a doctor.

• If bothersome dryness or peeling

occurs, reduce the application.

• Store dry at room temperature

Description

Drug Facts Active Ingredients Salicylic Acid  1.0%

Section 42229-5

Other Information Sunburn Alert.

This product contains an alpha hydroxy

acid (AHA) that may increase your skin's

sensitivity to the sun and particularly the

possibility of sunburn. Use a sunscreen,

wear protective clothing, and limit sun

exposure while using this product and

for a week afterwards.

Section 50565-1

Keep out of the reach of children. If

swallowed get medical help or contact

Poison Control Center right away.

Section 51727-6

Inactive ingredients Water,

Cetyl Alcohol, Dimethicone,

Caprylic/Capric Triglyceride, Glyceryl

Stearate Citrate, Ammonium

Acryloyldimethyltaurate/VP Copolymer,

Glycolic Acid, Squalane, Dicaprylyl

Carbonate, Glycerin, Phenoxyethanol,

Sodium Hydroxide, Isopentyldiol, Sodium

Stearoyl Glutamate, Polyacrylate

Crosspolymer-6, Dimethicone/Vinyl

Dimethicone Crosspolymer, Cladonia

Stellaris Extract (Alpine Caribou Moss™),

Ethylhexylglycerin, Gluconolactone,

Trifolium Pratense (Clover) Flower Extract,

Sodium Hyaluronate, Arctium Majus

(Burdock) Root Extract, Portulaca

Oleracea Extract, Sodium Benzoate

Section 53413-1

Questions or comments?

Email us at [email protected]

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Drug Facts

Active Ingredients

Salicylic Acid  1.0%

Product Packaging: Oars + Alps Anti Everything Face Moisturizer

OARS + ALPS

ANTI-EVERYTHING

FACE MOISTURIZER

1% SALICYLIC ACID

1.7 Fl. Oz. / 50 mL

Manufactured for

Oars + Alps LLC

Chicago, IL 60661

res 080624


Structured Label Content

Indications and Usage (34067-9)

Uses

• For the treatment of acne

• Reduces the number of acne pimples,

blackheads, whiteheads and allows

skin to heal

• Penetrates pores to clear most acne

blemishes

• Helps prevent new acne blemishes

from formlng

Dosage and Administration (34068-7)

Directions

• Squeeze 1-2 pumps on to fingertips.

Apply evenly on clean, dry skin at

night. Avoid eye area. Suggested use

in PM.

• At first, use every other day. Then

up to twice a day as tolerated

• Use sunscreen during the day while

using this product

• Because excessive drying of the skin

may occur, start with one application

daily, then gradually increase if needed

or as directed by a doctor.

• If bothersome dryness or peeling

occurs, reduce the application.

• Store dry at room temperature

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use if you have very sensitive

skin or known allergy to aspirin

Slop use and ask a doctor if

excessive itching, dryness, redness,

burning, or swelling occurs or if these

symptoms persist

When using this product • Keep

away from eyes, lips, and other

mucous membranes. If contact occurs,

flush thoroughly with water.• Using

other topical acne medications at the

same time or immediately following

use of this product may increase

dryness or irritation of the skin. If this

occurs, only one medication should be

used unless directed by doctor.

Section 42229-5 (42229-5)

Other Information Sunburn Alert.

This product contains an alpha hydroxy

acid (AHA) that may increase your skin's

sensitivity to the sun and particularly the

possibility of sunburn. Use a sunscreen,

wear protective clothing, and limit sun

exposure while using this product and

for a week afterwards.

Section 50565-1 (50565-1)

Keep out of the reach of children. If

swallowed get medical help or contact

Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients Water,

Cetyl Alcohol, Dimethicone,

Caprylic/Capric Triglyceride, Glyceryl

Stearate Citrate, Ammonium

Acryloyldimethyltaurate/VP Copolymer,

Glycolic Acid, Squalane, Dicaprylyl

Carbonate, Glycerin, Phenoxyethanol,

Sodium Hydroxide, Isopentyldiol, Sodium

Stearoyl Glutamate, Polyacrylate

Crosspolymer-6, Dimethicone/Vinyl

Dimethicone Crosspolymer, Cladonia

Stellaris Extract (Alpine Caribou Moss™),

Ethylhexylglycerin, Gluconolactone,

Trifolium Pratense (Clover) Flower Extract,

Sodium Hyaluronate, Arctium Majus

(Burdock) Root Extract, Portulaca

Oleracea Extract, Sodium Benzoate

Section 53413-1 (53413-1)

Questions or comments?

Email us at [email protected]

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Salicylic Acid  1.0%

Product Packaging: Oars + Alps Anti Everything Face Moisturizer (Product Packaging: OARS + ALPS ANTI-EVERYTHING FACE MOISTURIZER)

OARS + ALPS

ANTI-EVERYTHING

FACE MOISTURIZER

1% SALICYLIC ACID

1.7 Fl. Oz. / 50 mL

Manufactured for

Oars + Alps LLC

Chicago, IL 60661

res 080624


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