foster & thrive phenolated calamine lotion usp

foster & thrive phenolated calamine lotion usp
SPL v1
SPL
SPL Set ID 298171e1-2826-d33b-e063-6394a90a875a
Route
topical
Published
Effective Date 2024-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (160 mg) phenol (10 mg)
Inactive Ingredients
bentonite calcium hydroxide glycerin water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-12-17

Purpose

Skin Protectant

Description

Drug Facts


Medication Information

Warnings
  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.
Uses

Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Purpose

Skin Protectant

Description

Drug Facts

Principal Display Panel

Section 42229-5

Drug Facts

Ask A Doctor

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Active Ingredient

Calamine 8%

Other Information.

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

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

Directions (shake Well Before Using)

Adult and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using 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.


Structured Label Content

Warnings
  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.
Uses

Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Purpose

Skin Protectant

Principal Display Panel

Section 42229-5 (42229-5)

Drug Facts

Ask A Doctor (Ask a doctor)

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Active Ingredient

Calamine 8%

Other Information.

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

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

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 immediately.

Directions (shake Well Before Using) (directions (Shake well before using))

Adult and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)