Quality Choice 218.002/218af

Quality Choice 218.002/218af
SPL v3
SPL
SPL Set ID 1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693
Route
TOPICAL
Published
Effective Date 2025-02-26
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 2025-02-26

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 no 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

Distibuted by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC

Other Information

store at room temperature (59⁰ - 77⁰ 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

Principal Display Panel

NDC 83324-245-06

QC

QUALITY CHOICE

*Compare to CALADRYL CLEAR

Clear 

Anti-Itch

Lotion

External Analgesic/Skin Protectant

Relieves pain & itching caused by:

Poison Ivy, Poison Sumac, Poison Oak & Insect Bites

6 FL OZ (177 mL)

When Using This Product

•do not get into eyes

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 wash affected area of skin

adults and children 2 years of age and older - apply to affected area no 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)

Distibuted by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC

Other Information (Other information)

store at room temperature (59⁰ - 77⁰ 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-245-06

QC

QUALITY CHOICE

*Compare to CALADRYL CLEAR

Clear 

Anti-Itch

Lotion

External Analgesic/Skin Protectant

Relieves pain & itching caused by:

Poison Ivy, Poison Sumac, Poison Oak & Insect Bites

6 FL OZ (177 mL)

When Using This Product (When using this product)

•do not get into eyes

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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