Florasone

Florasone
SPL v12
SPL
SPL Set ID 0ea5879c-5955-427d-8604-a0677a4bb5cd
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.


Medication Information

Indications and Usage

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

Purpose

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

Description

Contains 10% Cardiospermum halicacabum tincture

Section 51945-4

Overdose

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

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.

Breast-feeding woman should not apply to breast area.

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.

Inactive Ingredient

Benzyl Alcohol

Cetyl Alcohol

Ethyl Alcohol

Glycerin

Glycol Stearate

Isopropyl Myristate

Mineral Oil

Potassium Hydroxide

Purified Water

Stearyl Heptanoate

active Ingredient

Contains 10% Cardiospermum halicacabum tincture

Dosage & Administration

Directions

Adults & children 6 years of age and older: apply to affected area up to 4 times daily; r ub 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.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

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

Overdose

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

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.

Breast-feeding woman should not apply to breast area.

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.

Inactive Ingredient

Benzyl Alcohol

Cetyl Alcohol

Ethyl Alcohol

Glycerin

Glycol Stearate

Isopropyl Myristate

Mineral Oil

Potassium Hydroxide

Purified Water

Stearyl Heptanoate

active Ingredient (Active Ingredient)

Contains 10% Cardiospermum halicacabum tincture

Indications and Usage

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

Dosage & Administration

Directions

Adults & children 6 years of age and older: apply to affected area up to 4 times daily; r ub 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


Raw Label Data

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