Swan 336.003/336ag

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 2016-09-08

Medication Information

Purpose

Skin protectant

External analgesic

Description

Calamine 8% Pramoxine HCl 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 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:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

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

swan _®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

Drying action plus itch relief
For relief from pain and itching due to:
Poison Ivy
Poison Sumac
Insect Bites
Poison Oak
Minor Skin Irritations

Compare to Caladryl ^®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 and Ask A Doctor If

condition worsens
symptoms last more than 7 days or clean 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

Skin protectant

External analgesic

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 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:

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

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)

swan _®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

Drying action plus itch relief
For relief from pain and itching due to:
Poison Ivy
Poison Sumac
Insect Bites
Poison Oak
Minor Skin Irritations

Compare to Caladryl ^®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 and Ask A Doctor If (Stop use and ask a doctor if )

condition worsens
symptoms last more than 7 days or clean up and occur again within a few days

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAVENDER OIL", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSEMARY OIL", "unii": "8LGU7VM393", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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": "Skin protectant External analgesic", "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 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: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593", "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": "swan ® Medicated Calamine Lotion External Analgesic/Skin Protectant Drying action plus itch relief For relief from pain and itching due to: Poison Ivy Poison Sumac Insect Bites Poison Oak Minor Skin Irritations Compare to Caladryl ® 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 and ask a doctor if ": "condition worsens symptoms last more than 7 days or clean up and occur again within a few days"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information