Florasone Cream

SPL v9

SPL

SPL Set ID f3b58e17-d694-4846-8d14-f5e0dd230ecf

Route

TOPICAL

Published

Effective Date 2025-11-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cardiospermum Halicacabum Flowering Top (1 [hp_X])

Inactive Ingredients

Benzyl Alcohol Cetyl Alcohol Glycol Stearate Glycerin Isopropyl Myristate Mineral Oil Potassium Hydroxide Water Stearyl Heptanoate Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2006-01-01

Description

Contains 10% Cardiospermum halicacabum Tincture

Indications and Usage

Temporarily relieves itch, rash, and skin irritation/inflammation.

Purpose

Temporarily relieves itch, rash, and skin irritation/inflammation.

Dosage and Administration

Directions Adults & children 6 years of age and older: apply to affected area up to 4 times daily. Rub in gently. Patch test recommended on sensitive skin.

Medication Information

Indications and Usage

Temporarily relieves itch, rash, and skin irritation/inflammation.

Purpose

Temporarily relieves itch, rash, and skin irritation/inflammation.

Dosage and Administration

Directions

Adults & children 6 years of age and older: apply to affected area up to 4 times daily. Rub in gently.

Patch test recommended on sensitive skin.

Description

Contains 10% Cardiospermum halicacabum Tincture

Section 51945-4

Stop Use

Stop use and ask a doctor if increased skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

These could be signs of a serious condition.

Warnings

For external use only. Avoid contact with eyes and broken skin.

Do Not Use

Do not use if hypersensitive to any ingredients in this product.

Breasting-feeding women should not apply to breast area.

Overdosage

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

Active Ingredient

Contains 10% Cardiospermum halicacabum Tincture

Inactive Ingredients

Benzyl Alcohol

Cetyl Alcohol

Ethyl Alcohol

Glycerin

Glycol Stearate

Isopropyl Myristate

Mineral Oil

Potassium Hydroxide

Purified water

Stearyl Heptanoate

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Structured Label Content

Section 51945-4 (51945-4)

Purpose

Temporarily relieves itch, rash, and skin irritation/inflammation.

Stop Use

These could be signs of a serious condition.

Warnings

For external use only. Avoid contact with eyes and broken skin.

Do Not Use

Do not use if hypersensitive to any ingredients in this product.

Breasting-feeding women should not apply to breast area.

Overdosage

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

Active Ingredient

Contains 10% Cardiospermum halicacabum Tincture

Inactive Ingredients

Benzyl Alcohol

Cetyl Alcohol

Ethyl Alcohol

Glycerin

Glycol Stearate

Isopropyl Myristate

Mineral Oil

Potassium Hydroxide

Purified water

Stearyl Heptanoate

Indications and Usage

Temporarily relieves itch, rash, and skin irritation/inflammation.

Dosage and Administration

Directions

Adults & children 6 years of age and older: apply to affected area up to 4 times daily. Rub in gently.

Patch test recommended on sensitive skin.

Pregnancy Or Breast Feeding (Pregnancy or Breast Feeding)

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children (Keep out of reach of Children)

Keep out of reach of children.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Purpose": "Temporarily relieves itch, rash, and skin irritation/inflammation.", "Stop Use": "Stop use and ask a doctor if increased skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days. These could be signs of a serious condition.", "Warnings": "For external use only. Avoid contact with eyes and broken skin.", "Do Not Use": "Do not use if hypersensitive to any ingredients in this product. Breasting-feeding women should not apply to breast area.", "Overdosage": "If swallowed, seek medical help or contact a Poison Control Center right away.", "Active Ingredient": "Contains 10% Cardiospermum halicacabum Tincture", "Inactive Ingredients": "Benzyl Alcohol Cetyl Alcohol Ethyl Alcohol Glycerin Glycol Stearate Isopropyl Myristate Mineral Oil Potassium Hydroxide Purified water Stearyl Heptanoate", "Indications and Usage": "Temporarily relieves itch, rash, and skin irritation/inflammation.", "Dosage and Administration": "Directions Adults & children 6 years of age and older: apply to affected area up to 4 times daily. Rub in gently. Patch test recommended on sensitive skin.", "Pregnancy or Breast Feeding": "If pregnant or breast-feeding, ask a healthcare professional before use.", "Keep out of reach of Children": "Keep out of reach of children."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:07.640767 · Updated: 2026-03-14T23:17:30.983574