Meijer 336.003/336ag

Meijer 336.003/336ag
SPL v7
SPL
SPL Set ID 6b369ef2-fd54-4931-a9eb-0fb42834c2ef
Route
TOPICAL
Published
Effective Date 2025-06-04
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 (synthetic) Hypromellose, Unspecified Lavender Oil Phenoxyethanol Polysorbate 80 Propylene Glycol Rosemary Oil Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-06-17

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

OUR QUALITY GUARANTEE

The Meijer Family

www.meijer.com/satisfaction

DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

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 Panel Display

NDC 79481-0336-1

Compare to Caladryl ®Lotion Active Ingredients*

meijer ®

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 Irration

Empty & Replace Cap

Plastic Bottle

how2recycle.info

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

OUR QUALITY GUARANTEE

The Meijer Family

www.meijer.com/satisfaction

DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

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 Panel Display

NDC 79481-0336-1

Compare to Caladryl ®Lotion Active Ingredients*

meijer ®

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 Irration

Empty & Replace Cap

Plastic Bottle

how2recycle.info

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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