Leader Calamine Plus

Leader Calamine Plus
SPL v5
SPL
SPL Set ID 81f29789-f794-1e64-e053-2a91aa0ac85e
Route
TOPICAL
Published
Effective Date 2019-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (80 mg) Pramoxine (10 mg)
Inactive Ingredients
Alcohol Camphor (synthetic) Diazolidinyl Urea Propylene Glycol Hypromelloses Glycerin Methylparaben Propylparaben Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-15
Description

For external use only Avoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age

Medication Information

Warnings and Precautions
  • For external use only
  • Avoid contact with eyes and mucous membranes
  • Ask a doctor before using on children under 2 years of age
Indications and Usage

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
Dosage and Administration

Adults and children 2 years 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 of 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.

Description

For external use only Avoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Section 51727-6

SH Alcohol 38B 2.5%

Camphor

Diazolidinyl Urea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparabaren

Purified water

Section 51945-4

Section 55105-1
  • Skin Protectant
  • External Analgesic
Section 55106-9

Calamine 8%

Pramoxine HCl 1%

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Adults and children 2 years 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 of 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.

Warnings and Precautions (34071-1)
  • For external use only
  • Avoid contact with eyes and mucous membranes
  • Ask a doctor before using on children under 2 years of age
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Section 51727-6 (51727-6)

SH Alcohol 38B 2.5%

Camphor

Diazolidinyl Urea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparabaren

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
  • Skin Protectant
  • External Analgesic
Section 55106-9 (55106-9)

Calamine 8%

Pramoxine HCl 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:34.444986 · Updated: 2026-03-14T23:02:13.859151