85056-003

85056-003
SPL v1
SPL
SPL Set ID 426c0602-63a5-104b-e063-6294a90ae964
Route
CUTANEOUS
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 g) .alpha.-tocopherol (1 g) Aloe (3 g) Witch Hazel
Inactive Ingredients
Petrolatum Glycerin Water Menthol Sodium Borate Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Zinc oxide 4% Witch Hazel 3% Vitamin E 1 % Aloe 1%

Purpose

Relieve itching and pain Reduces swelling, anti-inflammatory. Promotes wound healing. Moisturizing, repairing, anti-inflammatory.


Medication Information

Purpose

Relieve itching and pain

Reduces swelling, anti-inflammatory.

Promotes wound healing.

Moisturizing, repairing, anti-inflammatory.

Description

Zinc oxide 4% Witch Hazel 3% Vitamin E 1 % Aloe 1%

Use

1.Helps relieve the pain, itching and burning associated with hemorrhoids

2.Temporarily reduces the swelling associated with hemorrhoids and fissues

3.Temporarily protects irritated areas and inflamed perinatal skin

Section 50565-1

Keep out of reach of children, in case of excessive use, get help from a health professional right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or does

not improve within 7 days or bleeding occurs.

Section 50567-7

Do not exceed the recommended daily dosage unless as directed by a doctor.

Section 51945-4

Warnings

Warnings: For external and intrarectal use only

Ask a doctor or pharmacist before use if you are presently taking a prescription

drug.

Directions

Adults: When practical, cleanse the affected area with mild soap

and warm water and ring thoroughly. Gently dry by patting or blotting

with toilet tissue or a soft cloth before application of this product.

Children under12 year of age: Consult a doctor.

Do Not Use

1. Do not use the product with an applicator if the introduction of the applicator into the rectum causes additional pain.

Consult a doctor promptly.

2. Do not use if allergic to any of the ingredients, for pregnant or breast-feeding,ask a health professional before use.

Other Information

Keep away from direct sunlight or heat.

Store at room temperature 15°C-30°C(59°F-86°F)

Active Ingredient(s)

Zinc oxide 4%

Witch Hazel 3%

Vitamin E 1 %

Aloe 1%

Inactive Ingredients

Vaseline, Glycerol ,Deionized water,Menthol,Borax,Lanolin


Structured Label Content

Use

1.Helps relieve the pain, itching and burning associated with hemorrhoids

2.Temporarily reduces the swelling associated with hemorrhoids and fissues

3.Temporarily protects irritated areas and inflamed perinatal skin

Section 50565-1 (50565-1)

Keep out of reach of children, in case of excessive use, get help from a health professional right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does

not improve within 7 days or bleeding occurs.

Section 50567-7 (50567-7)

Do not exceed the recommended daily dosage unless as directed by a doctor.

Section 51945-4 (51945-4)

Purpose

Relieve itching and pain

Reduces swelling, anti-inflammatory.

Promotes wound healing.

Moisturizing, repairing, anti-inflammatory.

Warnings

Warnings: For external and intrarectal use only

Ask a doctor or pharmacist before use if you are presently taking a prescription

drug.

Directions

Adults: When practical, cleanse the affected area with mild soap

and warm water and ring thoroughly. Gently dry by patting or blotting

with toilet tissue or a soft cloth before application of this product.

Children under12 year of age: Consult a doctor.

Do Not Use (Do not use)

1. Do not use the product with an applicator if the introduction of the applicator into the rectum causes additional pain.

Consult a doctor promptly.

2. Do not use if allergic to any of the ingredients, for pregnant or breast-feeding,ask a health professional before use.

Other Information (Other information)

Keep away from direct sunlight or heat.

Store at room temperature 15°C-30°C(59°F-86°F)

Active Ingredient(s)

Zinc oxide 4%

Witch Hazel 3%

Vitamin E 1 %

Aloe 1%

Inactive Ingredients (Inactive ingredients)

Vaseline, Glycerol ,Deionized water,Menthol,Borax,Lanolin


Advanced Ingredient Data


Raw Label Data

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