leader poison ivy wash

leader poison ivy wash
SPL v5
SPL
SPL Set ID 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c
Route
topical
Published
Effective Date 2019-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pramoxine (10 mg)
Inactive Ingredients
ammonium lauryl sulfate propylparaben glycol distearate glycerin propylene glycol sodium hydroxide edetic acid nonoxynol-9 diazolidinyl urea water methylparaben hydrolyzed jojoba esters (acid form)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-15

Description

When using this product: avoid contact with eyes do not leave on skin longer than 3 minutes rinse thoroughly after application


Medication Information

Warnings and Precautions

When using this product:

  • avoid contact with eyes
  • do not leave on skin longer than 3 minutes
  • rinse thoroughly after application
Active Ingredient

Pramoxine HCl 1%

Indications and Usage

For temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac.

Dosage and Administration

Adults and children 2 years of age and older:

  • Wet the affected area
  • Apply product to affected skin and surrounding area
  • work foam into a lather and rub for up to 3 minutes, if needed
Description

When using this product: avoid contact with eyes do not leave on skin longer than 3 minutes rinse thoroughly after application

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, week professional assistance or contact a poison control center immediately. (1-800-222-1222)

Section 51727-6

Inactive Ingredients:

Water

Ammonium Lauryl Sulfate

Distearyl Phthalic Acid Amide

Glycol Distearate

Cocamide MIPA

Propylene Glycol

Diazolidinyl Urea

Methylparaben

Propylparaben Glycerin

Jojoba Esters

Disodium EDTA

Sodium Hydroxide

Nonxynol-9

Section 51945-4

Section 55105-1

External Analgesic


Structured Label Content

Warnings and Precautions (34071-1)

When using this product:

  • avoid contact with eyes
  • do not leave on skin longer than 3 minutes
  • rinse thoroughly after application
Active Ingredient (55106-9)

Pramoxine HCl 1%

Indications and Usage (34067-9)

For temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac.

Dosage and Administration (34068-7)

Adults and children 2 years of age and older:

  • Wet the affected area
  • Apply product to affected skin and surrounding area
  • work foam into a lather and rub for up to 3 minutes, if needed
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, week professional assistance or contact a poison control center immediately. (1-800-222-1222)

Section 51727-6 (51727-6)

Inactive Ingredients:

Water

Ammonium Lauryl Sulfate

Distearyl Phthalic Acid Amide

Glycol Distearate

Cocamide MIPA

Propylene Glycol

Diazolidinyl Urea

Methylparaben

Propylparaben Glycerin

Jojoba Esters

Disodium EDTA

Sodium Hydroxide

Nonxynol-9

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)