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Caladryl

Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

Caladryl Pink


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Calamine 8% Skin protectant
Pramoxine HCl 1% Topical analgesic

Caladryl Uses

  • temporarily relieves pain and itching associated with:
    • rashes due to poison ivy, poison oak or poison sumac
    • insect bites
    • minor skin irritation
    • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

When using this product do not get into eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before use
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Caladryl Other information

  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Questions?

call 1-800-223-0182

Dist: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Caladryl®

Topical Analgesic ∙ Skin Protectant
Lotion

Calamine Plus Itch Reliever

6 FL OZ (177 mL)

Caladryl

Caladryl

Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58232-0730
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ferric oxide red 1.36 mg
Zinc Oxide Zinc oxide 78.65 mg
pramoxine hydrochloride PRAMOXINE 10 mg

Inactive Ingredients

Ingredient Name Strength
CAMPHOR (SYNTHETIC)
DIAZOLIDINYL UREA
HYPROMELLOSES
METHYLPARABEN
polysorbate 80
propylene glycol
PROPYLPARABEN
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58232-0730-1 177 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2012-02-17


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Be sure to consult your doctor before taking any medication!
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