Rexall 218.002/218af

Rexall 218.002/218af
SPL v13
SPL
SPL Set ID 91df1434-bce6-4c6e-beee-cb5ec1cc8fff
Route
TOPICAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg) Zinc Cation (1 mg)
Inactive Ingredients
Alcohol Benzoic Acid Camphor (synthetic) Citric Acid Monohydrate Glycerin Hypromellose, Unspecified Lavender Oil Polysorbate 40 Rosemary Oil Sodium Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-06-30

Description

Pramoxine HCl 1% Zinc acetate 0.1%

Purpose

External analgesic Skin protectant


Medication Information

Purpose

External analgesic

Skin protectant

Description

Pramoxine HCl 1% Zinc acetate 0.1%

Uses
  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
  • dries the oozing and weeping of poison: - ivy - oak - sumac
Warnings

For external use only

Directions
  • shake well
  • before applying wash affected area of skin

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 - ask a doctor

Adverse Reaction

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 Mission Ridge

Goodlettsville, TN 37072 

Since 1903 Rexall ®is a registered trademark of Rexall Sundown, Inc.

A0154

Other Information

store at room temperature (59° - 77°F)

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Inactive Ingredients

alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

When Using This Product
  • do not get into eyes
Principal Display Panel

Since 1903

Rexall ®

Clear Anti-Itch Lotion

External Analgesic • Skin Protectant

For relief from pain and itching due  to:

  • Poison ivy, oak and sumac
  • Insect bites
  • Minor skin irritations

6 FL OZ (177 mL)

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use Section and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses
  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
  • dries the oozing and weeping of poison: - ivy - oak - sumac
Purpose

External analgesic

Skin protectant

Warnings

For external use only

Directions
  • shake well
  • before applying wash affected area of skin

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 - ask a doctor

Adverse Reaction (Adverse reaction)

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 Mission Ridge

Goodlettsville, TN 37072 

Since 1903 Rexall ®is a registered trademark of Rexall Sundown, Inc.

A0154

Other Information (Other information)

store at room temperature (59° - 77°F)

Active Ingredients (Active ingredients)

Pramoxine HCl 1%

Zinc acetate 0.1%

Inactive Ingredients (Inactive ingredients)

alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

When Using This Product (When using this product)
  • do not get into eyes
Principal Display Panel (principal display panel)

Since 1903

Rexall ®

Clear Anti-Itch Lotion

External Analgesic • Skin Protectant

For relief from pain and itching due  to:

  • Poison ivy, oak and sumac
  • Insect bites
  • Minor skin irritations

6 FL OZ (177 mL)

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use Section and Ask A Doctor If (Stop use section and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)