Equaline 336.003/336ag

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 2009-05-21

Medication Information

Purpose

Skin protectant

External analgesic

Description

Calamine 8% Pramoxine HCl 1%

Use

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 - do not use, ask a doctor

Disclaimer

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

Adverse Reaction

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

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

Compare to Caladryl ^®Lotion active ingredient*

NDC 41163-536-30

EQUALINE ^®

medicated calamine lotion

external analgesic

skin protectant

drying action plus itch relief

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 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

Use

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 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, LLA, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

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)

Compare to Caladryl ^®Lotion active ingredient*

NDC 41163-536-30

EQUALINE ^®

medicated calamine lotion

external analgesic

skin protectant

drying action plus itch relief

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 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

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Raw Label Data

All Sections (JSON)

{"Use": "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 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, LLA, distributor of Caladryl Lotion Calamine Plus Itch Reliever.", "ADVERSE REACTION": "DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630", "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": "Compare to Caladryl ® Lotion active ingredient* NDC 41163-536-30 EQUALINE ® medicated calamine lotion external analgesic skin protectant drying action plus itch relief 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 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information