Foster & Thrive Caldyphen Lotion

Foster & Thrive Caldyphen Lotion
SPL v1
SPL
SPL Set ID 29945734-4ea6-b702-e063-6294a90ae6f2
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (80 mg) Pramoxine (10 mg)
Inactive Ingredients
Camphor (natural) Diazolidinyl Urea Glycerin Hypromellose, Unspecified Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Drug Facts

Purpose

Skin Protectant External analgesic


Medication Information

Purpose

Skin Protectant

External analgesic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Questions?

Call 833-358-6431

Other Information

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

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Inactive Ingredients

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Principal Display Panel

When Using This Product

do not use if condition worsens, does not improve or if symptoms persist for more than 7 days or clear up and occur again within a few days, and consult a doctor.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Skin Protectant

External analgesic

Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Questions?

Call 833-358-6431

Other Information (Other information)

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

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Inactive Ingredients

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Principal Display Panel

When Using This Product (When using this product)

do not use if condition worsens, does not improve or if symptoms persist for more than 7 days or clear up and occur again within a few days, and consult a doctor.

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

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


Advanced Ingredient Data


Raw Label Data

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