Cottontails
FDA Label NDC 41520-341

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Cottontails (NDC 41520-341). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop using this product and ask a doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

LANOLIN 15.5%

PETROLATUM 53.4%

Purpose

SKIN PROTECTANT

Uses

HELPS TREAT AND PREVENT DIAPER RASH. TEMPORARILY PROTECTS MINOR CUTS, SCRAPES AND BURNS. TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFED OR CRACKED SKIN. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER

Warnings

FOR EXTERNAL USE ONLY

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER THOROUGHLY

Stop Using This Product And Ask A Doctor If

CONDITION WORSENS. SYMPTOMS LAST MORE THAN 7 DAYS. IF SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

Do Not Use On

DEEP OR PUNCTURE WOUNDS. ANIMAL BITES. SERIOUS BURNS

Keep Out Of Reach Of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Directions

FOR SKIN PROTECTANT USE. APPLY AS NEEDED.

FOR DIAPER RASH USE. CHANGE WET AND SOILED DIAPERS PROMPTLY. CLEAN THE DIAPER AREA AND ALLOW TO DRY. APPLY OINTMENT AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED

Other Information

STORE BETWEEN 20°-25°C (68°-77°F)

Inactive Ingredients

MICROCRYSTALLINE WAX, MINERAL OIL, PARAFFIN, FRAGRANCE (PARFUM), COD LIVER OIL (VITAMINS A & D)

Questions Or Comments?

1-866-695-3030

Label Copy

Image Of The Label (3501b)

Image Of The Label (3501b)

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