Good Sense 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 Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Good Sense ^®is a registered trademark of L. Perrigo Company.

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 75981-336-30

GoodSense _®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

Pain and Itch Reliever

Compare to active ingredients of 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 clear 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 Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Good Sense ^®is a registered trademark of L. Perrigo Company.

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 75981-336-30

GoodSense _®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

Pain and Itch Reliever

Compare to active ingredients of 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 clear up and occur again within a few days

Advanced Ingredient Data

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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 Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com 1-888-593-0593 Good Sense ® is a registered trademark of L. Perrigo Company.", "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 75981-336-30 GoodSense ® Medicated Calamine Lotion External Analgesic/Skin Protectant Pain and Itch Reliever Compare to active ingredients of 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 clear 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