sunmark caldyphen lotion

sunmark caldyphen lotion
SPL v5
SPL
SPL Set ID 4f4d4c54-64b5-4e20-bed0-c7fb470b8434
Route
topical
Published
Effective Date 2014-04-01
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 methylparaben polysorbate 80 propylene glycol propylparaben water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1998-03-25

Purpose

Skin Protectant External analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only. Use only as directed.

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

Uses

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

Purpose

Skin Protectant

External analgesic

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.

Other Information

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

Inactive Ingredients

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

Description

Drug Facts

Principal Display Panel

Label

Section 42229-5

Drug Facts

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Stop Ue and Ask A Doctor If

condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only. Use only as directed.

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

Uses

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

Purpose

Skin Protectant

External analgesic

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.

Other Information (Other information)

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

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

Label

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Stop Ue and Ask A Doctor If (Stop ue and ask a doctor if)

condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.

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.


Advanced Ingredient Data


Raw Label Data

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