Good Sense 218.002/218af

Good Sense 218.002/218af
SPL v5
SPL
SPL Set ID cc0378f2-6d5f-47ec-b16a-64668b4c29cc
Route
TOPICAL
Published
Effective Date 2025-08-26
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 2008-07-24

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

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl ® Clear ® Lotion.

Adverse Reaction

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense ®is a registered trademark of L. Perrigo Company.

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

Principal Display Panel

NDC 75981-218-30

GoodSENSE ®

Clear Anti-Itch Lotion

External Analgesic/Skin Protectant

Pain and Itch Reliever

Compare to active ingredients of Caladryl ® Clear ® Lotion*

6 FL OZ (177 mL)

When Using This Product
  • do not get into eyes
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

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl ® Clear ® Lotion.

Adverse Reaction (Adverse reaction)

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense ®is a registered trademark of L. Perrigo Company.

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

Principal Display Panel

NDC 75981-218-30

GoodSENSE ®

Clear Anti-Itch Lotion

External Analgesic/Skin Protectant

Pain and Itch Reliever

Compare to active ingredients of Caladryl ® Clear ® Lotion*

6 FL OZ (177 mL)

When Using This Product (When using this product)
  • do not get into eyes
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)