Quality Choice 336.003/336ag

Quality Choice 336.003/336ag
SPL v3
SPL
SPL Set ID 6c848b98-f01c-40f2-a9aa-2af76cb370c8
Route
TOPICAL
Published
Effective Date 2025-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferric Oxide Red (80 mg) Pramoxine (10 mg)
Inactive Ingredients
Alcohol Benzyl Alcohol Camphor (natural) Hypromellose, Unspecified Lavender Oil Phenoxyethanol Polysorbate 80 Propylene Glycol Rosemary Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-26

Description

Calamine 8% Pramoxine HCl 1%

Purpose

Skin protectant External analgesic


Medication Information

Purpose

Skin protectant

External analgesic

Description

Calamine 8% Pramoxine HCl 1%

Uses
  • for the temporary relief of pain and itching associated with minot 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 - do not use, ask a doctor

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Adverse Reaction

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC

Other Information

store at room temperature (59°-77°F)

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Inactive Ingredients

alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

Principal Display Panel

NDC 83324-053-06

QC

QUALITY CHOICE

*Compare to CALADRYL

Medicated

Calamine

Lotion

External Analgesic/Skin Protectant

For relief from pain and itching due to:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations

6 FL OZ (177 mL)

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor
  • condition worsens
  • symptoms last more than 7 days or clean 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 minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • dries the oozing and weeping of poison:
  • ivy
  • oak
  • sumac
Purpose

Skin protectant

External analgesic

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 - do not use, ask a doctor

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Adverse Reaction (ADVERSE REACTION)

Distributed 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 (59°-77°F)

Active Ingredients (Active ingredients)

Calamine 8%

Pramoxine HCl 1%

Inactive Ingredients (Inactive ingredients)

alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-053-06

QC

QUALITY CHOICE

*Compare to CALADRYL

Medicated

Calamine

Lotion

External Analgesic/Skin Protectant

For relief from pain and itching due to:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations

6 FL OZ (177 mL)

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • condition worsens
  • symptoms last more than 7 days or clean 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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