71614-002_parma Anus Skin Premium Cleanser

71614-002_parma Anus Skin Premium Cleanser
SPL v6
SPL
SPL Set ID 9694aea6-db34-409e-b4fb-4d4fe6fd33fa
Route
TOPICAL
Published
Effective Date 2018-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (3 mg)
Inactive Ingredients
Sapindus Mukorossi Fruit Asian Ginseng Polysorbate 85 1,2-hexanediol Medium-chain Triglycerides Water Hydroxyethyl Cellulose (100 Mpa.s At 2%) Mandelic Acid Edetate Disodium Anhydrous Oleic Acid Lauryl Glucoside Butylene Glycol Diglycerin Sodium Cocoate Coco Monoisopropanolamide Nepidermin Acetyl Hexapeptide-8 Sodium Cocoamphoacetate Rice Bran Artemisia Vulgaris Root Mung Bean Centella Asiatica Purslane Rheum Palmatum Root Bambusa Vulgaris Top Eucalyptus Globulus Leaf Hamamelis Virginiana Top Matricaria Chamomilla Flowering Top Propolis Wax

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-08-27

Description

Allantoin 0.3%


Medication Information

Warnings and Precautions

For external use only.

Do not use on damaged or broken skin.

Rinse with water to remove.

Stop use and ask a doctor if rash or irritation occurs.

Indications and Usage

Anus Cleansing

Dosage and Administration

Wet anal area thoroughly.

Apply an appropriate amount of the product to anal area. Massage anus and maintain 30 seconds. Rinse with water for 60 seconds.

Description

Allantoin 0.3%

Section 50565-1

Keep out of reach of children

Section 51727-6

Water

Hydroxyethylcellulose

Black Strap Powder

Mandelic Acid

Disodium EDTA

Oleic Acid

Lauryl Glucoside

Butylene Glycol

Diglycerin

Sodium Cocoate

Cocamide MIPA

sh-Oligopeptide-1

Acetyl Hexapeptide-8

Shea Butteramidopropyl Betaine

Sodium Cocoamphoacetate

Oryza Sativa (Rice) Bran Extract

Artemisia Vulgaris Extract

Phaseolus Radiatus Seed Extract

Centella Asiatica Extract

Portulaca Oleracea Extract

Crataegus Oxyacantha Extract

Rheum Palmatum Root Extract

Bambusa Vulgaris Extract

Eucalyptus Globulus Leaf Extract

Hamamelis Virginiana (Witch Hazel) Extract

Chamomilla Recutita (Matricaria) Flower/Leaf Extract

Propolis Extract

Sapindus Mukorossi Fruit Extract

Panax Ginseng Root Extract

Polysorbate 85

1,2-Hexanediol

Caprylic/Capric Triglyceride

Fragrance

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Allantoin 0.3%


Structured Label Content

Indications and Usage (34067-9)

Anus Cleansing

Dosage and Administration (34068-7)

Wet anal area thoroughly.

Apply an appropriate amount of the product to anal area. Massage anus and maintain 30 seconds. Rinse with water for 60 seconds.

Warnings and Precautions (34071-1)

For external use only.

Do not use on damaged or broken skin.

Rinse with water to remove.

Stop use and ask a doctor if rash or irritation occurs.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water

Hydroxyethylcellulose

Black Strap Powder

Mandelic Acid

Disodium EDTA

Oleic Acid

Lauryl Glucoside

Butylene Glycol

Diglycerin

Sodium Cocoate

Cocamide MIPA

sh-Oligopeptide-1

Acetyl Hexapeptide-8

Shea Butteramidopropyl Betaine

Sodium Cocoamphoacetate

Oryza Sativa (Rice) Bran Extract

Artemisia Vulgaris Extract

Phaseolus Radiatus Seed Extract

Centella Asiatica Extract

Portulaca Oleracea Extract

Crataegus Oxyacantha Extract

Rheum Palmatum Root Extract

Bambusa Vulgaris Extract

Eucalyptus Globulus Leaf Extract

Hamamelis Virginiana (Witch Hazel) Extract

Chamomilla Recutita (Matricaria) Flower/Leaf Extract

Propolis Extract

Sapindus Mukorossi Fruit Extract

Panax Ginseng Root Extract

Polysorbate 85

1,2-Hexanediol

Caprylic/Capric Triglyceride

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Allantoin 0.3%


Advanced Ingredient Data


Raw Label Data

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