BOTTOMS UP HEALTH

Manufacturer
CENTURA PHARMACEUTICALS INC
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:41:51

Label at a glance#

ProductBOTTOMS UP HEALTH
Active ingredientLIDOCAINE, GLYCERIN, ZINC OXIDE, WITCH HAZEL
Label structure14 sections

Indications and uses

Helps relieve the pain, burning, soreness and itching associated with inflamed hemorrhoidal tissue and other anorectal disorders. Temporarily protects inflamed and irritated anorectal surface to help make bowel movements less.

Dosage and administration

Adults and children over 12 years old ■ Apply externally to affected area up to 6 times a day or after each bowel movement ■ Clean affected area with mild soap and warm water, rinse thoroughly and gently dry by patting or blotting with toilet tissue or a soft cloth before using this product. ■ Children under 12 years of age: consult a doctor.

Storage and handling

Store at room temperature and away from direct sunlight.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Calamine 15%

Glycerin 35%

Lidocaine 5%

Witch Hazel 10%

PURPOSE

OTC - PURPOSE SECTION

Protectant, Protectant, Anesthetic, Protectant

USES

INDICATIONS & USAGE SECTION

Helps relieve the pain, burning, soreness and itching associated with inflamed hemorrhoidal tissue and other anorectal disorders.

Temporarily protects inflamed and irritated anorectal surface to help make bowel movements less.

WARNINGS

WARNINGS SECTION

For external use only

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

■ the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase ■ condition worsens or does not improve within 7 days

ALLERGY ALERT

OTHER SAFETY INFORMATION

Certain persons can develop allergic reactions to ingredients in this product.

OTHER WARNINGS

OTHER SAFETY INFORMATION

Do not exceed the recommended dose unless directed by a doctor.

In case of bleeding, consult a doctor promptly.

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

IF PREGNANT OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years old ■ Apply externally to affected area up to 6 times a day or after each bowel movement

■ Clean affected area with mild soap and warm water, rinse thoroughly and gently dry by patting or blotting with toilet tissue or a soft cloth before using this product.

■ Children under 12 years of age: consult a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature and away from direct sunlight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Behentrimonium Methosulfate, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Glyceryl Stearate, lsopropyl Palmitate, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Silica.

QUESTIONS

OTC - QUESTIONS SECTION

813-666-7867

PACKAGE LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABELINGPACKAGE LABELING

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70372-731BOTTOMS UP HEALTH (LIDOCAINE,GLYCERIN,CALAMINE,WITCH HAZEL) CREAM [CENTURA PHARMACEUTICALS INC]4Unmatched20250129_f25581e6-8457-8fa1-e053-2a95a90a61df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70372-73170372-731-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4885579a-546d-2bdc-e063-6394a90a8ee2f25581e6-8457-8fa1-e053-2a95a90a61df2026-01-16WarningsExact identifier
spl set id: f25581e6-8457-8fa1-e053-2a95a90a61df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.