Sunmark Caldyphen Clear description, usages, side effects, indications, overdosage, supplying and lots more!

Sunmark Caldyphen Clear

McKesson

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Sunmark Caldyphen Clear Lotion

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Zinc Acetate 8%

Pramoxine HCl 1%

Purpose

Skin Protectant

External analgesic

Uses

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

Warnings

For external use only. Use only as directed.

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

Ask a doctor before using on children 2 years of age.

Stop use and ask a doctor if

condition worsens. Symptoms last for more than 7 days 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.

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.

Inactive Ingredients

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

Other information

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

Principal display panel

Label

Principal display panel

Sunmark Caldyphen Clear

Zinc Acetate and Pramoxine Hydrochloride LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-610
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 80 mg
pramoxine hydrochloride PRAMOXINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CAMPHOR (NATURAL)
DIAZOLIDINYL UREA
GLYCERIN
METHYLPARABEN
polysorbate 80
propylene glycol
PROPYLPARABEN
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-610-36 177 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 1998-03-25


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