Basics 336.003/336ag

Basics 336.003/336ag
SPL v6
SPL
SPL Set ID aceb0b10-8c90-4a06-8c47-cd1a2b4676a3
Route
TOPICAL
Published
Effective Date 2025-05-19
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 2018-05-21

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 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

Adverse Reaction

DISTRIBUTED BY: Amazon.com, Services, LLC

Seattle, WA 98109     1-877-485-0385

2022 Amazon.com, Inc. or its affiliated.

All rights reserved.   www.amazon.com/amazonbasics

"Alexa, reorder Amazon Basics Anti-Itch Lotion." alexa

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

amazon basics

medicated

calamine lotion

External Analgesic

Skin Protectant

Anti-itch lotion

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 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

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY: Amazon.com, Services, LLC

Seattle, WA 98109     1-877-485-0385

2022 Amazon.com, Inc. or its affiliated.

All rights reserved.   www.amazon.com/amazonbasics

"Alexa, reorder Amazon Basics Anti-Itch Lotion." alexa

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)

amazon basics

medicated

calamine lotion

External Analgesic

Skin Protectant

Anti-itch lotion

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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