SPL v1
SPL
SPL Set ID 2f30fc45-42e2-c766-e063-6394a90a8d68
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Microcrystalline Cellulose (5 g) Butyrospermum Parkii (shea) Butter (1 g) Beeswax (0.5 g) Betaine (3 g)
Inactive Ingredients
Propylene Glycol Peg-100 Stearate Tocopherol Xanthan Gum Simmondsia Chinensis (jojoba) Seed Oil Stearic Acid Lactic Acid Camellia Sinensis Leaf Glyceryl Caprylate Ethylhexyl Palmitate Allantoin Behenyl Alcohol Carbomer 1,2-hexanediol Chrysanthellum Indicum Whole Glyceryl Stearate Aloe Barbadensis Leaf Hydroxypropyl Methylcellulose Cladosiphon Okamuranus Whole Peg-20 Methyl Glucose Sesquistearate Butylene Glycol Aqua Cetearyl Alcohol

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-10

Description

NET WT. 30 G /1 OZ


Medication Information

Warnings and Precautions

For external use only. Keep out of reach of children.Avoid contact with eyes.

Indications and Usage



1. Apply to clean skin.

2. Gently massage a liberal amount of exfoliating scrub onto damp skin in circular motions.

3. Rinse thoroughly with water to reveal fresh and radiant skin.

Dosage and Administration

NET WT. 30 G /1 OZ

Description

NET WT. 30 G /1 OZ

Section 42232-9

1.For External Use Only.

2.Avoid Direct Contact with Eyes.

3.If the product gets into your eyes, rinse immediately with plenty of water.

4.Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.

5.Do Not Apply on Broken or Irritated Skin.

Section 50565-1

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

Section 51727-6

AQUA

BUTYLENE GLYCOL

PROPYLENE GLYCOL

CETEARYL ALCOHOL

ETHYLHEXYL PALMITATE

LACTIC ACID

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

STEARIC ACID

PEG-100 STEARATE

GLYCERYL STEARATE

PEG-20 METHYL GLUCOSE SESQUISTEARATE

BEHENYL ALCOHOL

TOCOPHEROL

CAMELLIA SINENSIS LEAF EXTRACT

CHRYSANTHELLUM INDICUM EXTRACT

ALOE BARBADENSIS LEAF EXTRACT

HYDROXYPROPYL METHYLCELLULOSE

CLADOSIPHON OKAMURANUS EXTRACT

CARBOMER

XANTHAN GUM

1,2-HEXANEDIOL

ALLANTOIN

GLYCERYL CAPRYLATE

Section 51945-4

Section 55105-1

Exfoliate, deeply cleanse pores and stimulate the skin's metabolism.


Structured Label Content

Indications and Usage (34067-9)



1. Apply to clean skin.

2. Gently massage a liberal amount of exfoliating scrub onto damp skin in circular motions.

3. Rinse thoroughly with water to reveal fresh and radiant skin.

Dosage and Administration (34068-7)

NET WT. 30 G /1 OZ

Warnings and Precautions (34071-1)

For external use only. Keep out of reach of children.Avoid contact with eyes.

Section 42232-9 (42232-9)

1.For External Use Only.

2.Avoid Direct Contact with Eyes.

3.If the product gets into your eyes, rinse immediately with plenty of water.

4.Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist.

5.Do Not Apply on Broken or Irritated Skin.

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 51727-6 (51727-6)

AQUA

BUTYLENE GLYCOL

PROPYLENE GLYCOL

CETEARYL ALCOHOL

ETHYLHEXYL PALMITATE

LACTIC ACID

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

STEARIC ACID

PEG-100 STEARATE

GLYCERYL STEARATE

PEG-20 METHYL GLUCOSE SESQUISTEARATE

BEHENYL ALCOHOL

TOCOPHEROL

CAMELLIA SINENSIS LEAF EXTRACT

CHRYSANTHELLUM INDICUM EXTRACT

ALOE BARBADENSIS LEAF EXTRACT

HYDROXYPROPYL METHYLCELLULOSE

CLADOSIPHON OKAMURANUS EXTRACT

CARBOMER

XANTHAN GUM

1,2-HEXANEDIOL

ALLANTOIN

GLYCERYL CAPRYLATE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Exfoliate, deeply cleanse pores and stimulate the skin's metabolism.


Advanced Ingredient Data


Raw Label Data

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