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

Purpose

Skin protectant

Description

Drug Facts


Medication Information

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.

Uses

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

Purpose

Skin protectant

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)

Inactive Ingredients

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

Description

Drug Facts

Label

Section 42229-5

Drug Facts

Questions

Questions or Comments? 1-833-551-0932

Active Ingredients

Calamine 8% and Zinc Oxide 8%

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

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.

Uses

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

Purpose

Skin protectant

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)

Inactive Ingredients (Inactive ingredients)

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

Label (label)

Section 42229-5 (42229-5)

Drug Facts

Questions

Questions or Comments? 1-833-551-0932

Active Ingredients

Calamine 8% and Zinc Oxide 8%

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

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