Caladryl Pink

Caladryl Pink
SPL v6
SPL
SPL Set ID 67d4fd42-9fed-4238-9f5a-c9403abbcf20
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferric Oxide Red (1.36 mg) Zinc Oxide (78.65 mg) Pramoxine (10 mg)
Inactive Ingredients
Camphor (synthetic) Diazolidinyl Urea Hypromellose, Unspecified Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-08-16
Description

Drug Facts

Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this productdo not get into eyes

Section 50569-3

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
Section 55105-1
Active ingredients Purpose

Calamine 8%

Skin protectant

Pramoxine HCl 1%

Topical analgesic
Warnings

For external use only.

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
Other Information
  • store at 20° to 25°C (68° to 77°F)
Questions/comments

call 1-800-321-4576

Inactive Ingredients

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

Principal Display Panel 177 Ml Bottle Label

Caladryl ®

Topical Analgesic ∙ Skin Protectant

Lotion

Calamine PlusItch Reliever

6 FL OZ (177 mL)

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this productdo not get into eyes

Section 50569-3 (50569-3)

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
Section 55105-1 (55105-1)
Active ingredients Purpose

Calamine 8%

Skin protectant

Pramoxine HCl 1%

Topical analgesic
Warnings

For external use only.

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
Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
Questions/comments (Questions/Comments)

call 1-800-321-4576

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 177 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label)

Caladryl ®

Topical Analgesic ∙ Skin Protectant

Lotion

Calamine PlusItch Reliever

6 FL OZ (177 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:52.614100 · Updated: 2026-03-14T23:04:12.212732