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SPL v2
SPL
SPL Set ID 2cc9fb86-50dc-4c2e-b83d-f96826ffd9ab
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (25.0 g) Kaolin (12.5 g) Zinc Cation (1.0 g) Menthol
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetostearyl Alcohol Water Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Isopropyl Palmitate Magnesium Aluminum Silicate Phenoxyethanol Polysorbate 20 Propylene Glycol Alcohol Silicon Dioxide Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For rectal use only

Do not use unless a prior doctor’s diagnosis of anorectal condition has been made

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days

• allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain,

other symptoms develop or increase • Do not put this product into the rectum by using fingers or any

mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product

because they interfere with the ability of this product to adhere properly to the skin area.

If pregnant or breastfeeding, ask a health professional before use

Indications and Usage

Uses • Helps relieve the itching and discomfort associated with anorectal disorders •

Provides temporary relief from the symptoms of perianal skin irritation • For the temporary

relief of itching associated with moist anorectal conditions • For the temporary relief of

irritation and burning

Dosage and Administration

Directions

Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

Apply a pea size amount of cream externally to the anal area and to the inner rim of the anus,

not deep into the rectum. • Children under 12 years of age: consult a doctor • Apply externally to the

affected area once or twice daily when pain or irritation is present.

Description

Drug Facts

Section 42229-5

Drug Facts

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

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,

Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate,

Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol

Section 53413-1

Questions or Comments? Email: [email protected]

Section 55105-1

Purposes

Glycerin ....................................................Protectant

Kaolin .........................................Protectant/Anti-Itch

Calamine ....................................Protectant/Anti-Itch

Menthol .....................................................Analgesic

Section 55106-9

Active Ingredients

Glycerin      25%

Kaolin        12.5%

Calamine   12.5%

Menthol        1%

Section 60561-8

Other Information: Do not use if tube seal is cut, broken or missing. • store at 15-30º C (59-86º F)

No More Product Labeling

No More Products

Net Wt. 1.25oz (35g)

Manufactured by Sarati Intn'i, 27502 Ted Hunt Rd., Los Fresnos TX  78566

www.nomoreproducts.com

No More Fissure Box

No More Fissure Tube

No More Hemorrhoids Box

No More Hemorrhoids Tube

No More Pruritus Box

No More Pruritus Tube

RES


Structured Label Content

Indications and Usage (34067-9)

Uses • Helps relieve the itching and discomfort associated with anorectal disorders •

Provides temporary relief from the symptoms of perianal skin irritation • For the temporary

relief of itching associated with moist anorectal conditions • For the temporary relief of

irritation and burning

Dosage and Administration (34068-7)

Directions

Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

Apply a pea size amount of cream externally to the anal area and to the inner rim of the anus,

not deep into the rectum. • Children under 12 years of age: consult a doctor • Apply externally to the

affected area once or twice daily when pain or irritation is present.

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Do not use unless a prior doctor’s diagnosis of anorectal condition has been made

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days

• allergic reaction develops • symptoms being treated do not subside or if redness, irritation, swelling, pain,

other symptoms develop or increase • Do not put this product into the rectum by using fingers or any

mechanical device or applicator. • Remove petrolatum or greasy ointment before using this product

because they interfere with the ability of this product to adhere properly to the skin area.

If pregnant or breastfeeding, ask a health professional before use

Section 42229-5 (42229-5)

Drug Facts

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)

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,

Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate,

Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol

Section 53413-1 (53413-1)

Questions or Comments? Email: [email protected]

Section 55105-1 (55105-1)

Purposes

Glycerin ....................................................Protectant

Kaolin .........................................Protectant/Anti-Itch

Calamine ....................................Protectant/Anti-Itch

Menthol .....................................................Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Glycerin      25%

Kaolin        12.5%

Calamine   12.5%

Menthol        1%

Section 60561-8 (60561-8)

Other Information: Do not use if tube seal is cut, broken or missing. • store at 15-30º C (59-86º F)

No More Product Labeling

No More Products

Net Wt. 1.25oz (35g)

Manufactured by Sarati Intn'i, 27502 Ted Hunt Rd., Los Fresnos TX  78566

www.nomoreproducts.com

No More Fissure Box

No More Fissure Tube

No More Hemorrhoids Box

No More Hemorrhoids Tube

No More Pruritus Box

No More Pruritus Tube

RES


Advanced Ingredient Data


Raw Label Data

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