Top Care 218.002/218af

Top Care 218.002/218af
SPL v21
SPL
SPL Set ID 8d3d1ff5-4868-495d-807c-e45aa2176f63
Route
TOPICAL
Published
Effective Date 2025-07-16
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 (natural) Citric Acid Monohydrate Glycerin Hypromellose, Unspecified Lavender Oil Polysorbate 40 Rosemary Oil Sodium Citrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-06-03

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 was affected are 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 of age - ask a doctor

Disclaimer

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

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0622 Questions? 1-888-423-0139

[email protected]  www.topcarebrand.com

Visit here for more information: http:/topbrnds.com/4901jl

Quality Guaranteed

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

TopCare ®health

NDC 36800-218-30

COMPARE TO CALADRYL ®CLEAR ®LOTION ACTIVE INGREDIENTS*

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC / SKIN PROTECTANT

For Relief of Pain and Itching Due To:

  • Poison Ivy, Oak or Sumac
  • Insect Bites
  • Minor Skin Irritations

6 FL OZ (177 mL)

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

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


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 was affected are 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 of age - ask a doctor

Disclaimer

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

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0622 Questions? 1-888-423-0139

[email protected]  www.topcarebrand.com

Visit here for more information: http:/topbrnds.com/4901jl

Quality Guaranteed

Other Information (Other information)

store at room temperature (59°-77°F)

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)

TopCare ®health

NDC 36800-218-30

COMPARE TO CALADRYL ®CLEAR ®LOTION ACTIVE INGREDIENTS*

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC / SKIN PROTECTANT

For Relief of Pain and Itching Due To:

  • Poison Ivy, Oak or Sumac
  • Insect Bites
  • Minor Skin Irritations

6 FL OZ (177 mL)

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


Advanced Ingredient Data


Raw Label Data

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