SPL v2
SPL
SPL Set ID 32434c1e-a6e8-73b8-e063-6294a90a64f1
Route
ORAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrantel (144 mg)
Inactive Ingredients
Methylcellulose (100 Cps) Dimethicone Povidone Sorbitol Lecithin, Soybean Glycerin Magnesium Aluminum Silicate Water Citric Acid Sodium Benzoate Sodium Citrate Sodium Saccharin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-01-01

Description

Iron Powder 45%


Medication Information

Description

Iron Powder 45%

Uses

Provides temporary relief from menstrual cramp pain and associated muscle aches.

Lable

Section 43683-2

no

Warning

For external use only. Do not wear this product directly on skin.

Directions

Take Heating Patch out ofpackaging.Use immediatelyafter package is opened.

Remove paper from theadhesive backing.

Place on pain area againsunderwear/clothing, not against skin.

Active Ingredient

Iron Powder 45%

Other Information

Store in a cool, dry place.

This is not a toy and should be kept out of reach of young children.

Discard the product if the packaging has been opened. Do not use.

Inactive Ingredient

Activated Charcoal, Sodium Polyacrylate (2500000 MW), Sodium Chloride, Water.

Dosage & Administration

Apply as needed

When Using This Product

Do not wear this product directly on skin.

Be aware of low-temperature burns.

Stop Use and Ask A Doctor If

pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.

Keep Out of Reach of Children.

if swallowed, call poison control or seek medical help.


Structured Label Content

Uses (USES)

Provides temporary relief from menstrual cramp pain and associated muscle aches.

Lable

Section 43683-2 (43683-2)

no

Warning

For external use only. Do not wear this product directly on skin.

Directions

Take Heating Patch out ofpackaging.Use immediatelyafter package is opened.

Remove paper from theadhesive backing.

Place on pain area againsunderwear/clothing, not against skin.

Active Ingredient (Active ingredient)

Iron Powder 45%

Other Information (Other information)

Store in a cool, dry place.

This is not a toy and should be kept out of reach of young children.

Discard the product if the packaging has been opened. Do not use.

Inactive Ingredient (Inactive ingredient)

Activated Charcoal, Sodium Polyacrylate (2500000 MW), Sodium Chloride, Water.

Dosage & Administration (Dosage & administration)

Apply as needed

When Using This Product (When using this product)

Do not wear this product directly on skin.

Be aware of low-temperature burns.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.

Keep Out of Reach of Children. (Keep out of reach of children.)

if swallowed, call poison control or seek medical help.


Advanced Ingredient Data


Raw Label Data

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