equaline 336.003/336ag

equaline 336.003/336ag
SPL v7
SPL
SPL Set ID 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea
Route
topical
Published
Effective Date 2025-06-02
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 2009-05-21

Purpose

Skin protectant External analgesic

Description

Calamine 8% Pramoxine HCl 1%


Medication Information

Warnings

For external use only

Purpose

Skin protectant

External analgesic

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

Other Information

store at room temperature (59°-77°F)

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

Description

Calamine 8% Pramoxine HCl 1%

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)

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
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

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

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

Warnings

For external use only

Purpose

Skin protectant

External analgesic

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

Other Information (Other information)

store at room temperature (59°-77°F)

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)

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
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

Active Ingredients (Active ingredients)

Calamine 8%

Pramoxine HCl 1%

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


Raw Label Data

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