Freskaro Calamine Lotion

Freskaro Calamine Lotion
SPL v2
SPL
SPL Set ID fbcfa541-beda-06de-e053-6294a90a9298
Route
TOPICAL
Published
Effective Date 2023-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferric Oxide Red (80 mg) Zinc Cation
Inactive Ingredients
Bentonite Carrageenan Xanthan Gum Calcium Hydroxide Glycerin Water Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-16

Description

Drug Facts

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Label

Section 42229-5

Drug Facts

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren under 2 years of age.

Questions

Questions or Comments? 1-833-551-0932

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years of age: Consult a doctor before use

Other Information

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

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Inactive Ingredients

Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum

Stop Use and Ask A Doctor If

condition worsens, does not improve or if symptoms last more than 7 days, or clear up and occur again within a few days.

Keep Out of Reach of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Label (label)

Section 42229-5 (42229-5)

Drug Facts

Purpose

Skin protectant

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren under 2 years of age.

Questions

Questions or Comments? 1-833-551-0932

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years of age: Consult a doctor before use

Other Information (Other information)

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

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Inactive Ingredients (Inactive ingredients)

Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, does not improve or if symptoms last more than 7 days, or clear up and occur again within a few days.

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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)