Foster & Thrive Caldyphen Lotion Clear

Foster & Thrive Caldyphen Lotion Clear
SPL v1
SPL
SPL Set ID 29946912-9794-8a8e-e063-6394a90a279e
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg) Zinc Cation (1 mg)
Inactive Ingredients
Camphor (natural) Diazolidinyl Urea Alcohol 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

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Drug Facts

Use

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

Label

Section 42229-5

Drug Facts

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Directions
  • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion 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.
Questions?

Call 833-358-6431

Active Ingredient

Pramoxine HCl 1%

Other Information
  • store at room temperature 15 o – 30 oC (59 o – 86 oF)
Inactive Ingredient

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

When Using This Product

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.

Ask A Doctor Before Using

on children under 2 years of age.

Keep Out of Reach of Children.

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


Structured Label Content

Use

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

Label

Section 42229-5 (42229-5)

Drug Facts

Purpose

External Analgesic

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Directions
  • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion 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.
Questions?

Call 833-358-6431

Active Ingredient

Pramoxine HCl 1%

Other Information
  • store at room temperature 15 o – 30 oC (59 o – 86 oF)
Inactive Ingredient

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

When Using This Product (When using this product)

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.

Ask A Doctor Before Using (Ask a doctor before using)

on children under 2 years of age.

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.


Advanced Ingredient Data


Raw Label Data

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