SPL v3
SPL
SPL Set ID 3d7026b8-d2cb-f4ab-e063-6294a90aeedd
Route
TOPICAL
Published
Effective Date 2025-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Retatrutide (20 mg)
Inactive Ingredients
Cellulose, Microcrystalline Polyvinyl Alcohol, Unspecified Sucrose Dimethicone, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-24

Description

Retatrutide 20 mg ……………………………. Weight management / blood sugar control

Purpose

Weight loss aid Improves blood sugar control (when used with diet and exercise)

Dosage and Administration

• Apply one transdermal patch containing 20 mg Retatrutide to the wrist or the back of the hand. • Leave the patch in place for 30 to 60 minutes, then remove. • Administer once every 3 to 7 days. • Do not reuse a patch. • Use only as directed.


Medication Information

Purpose

Weight loss aid

Improves blood sugar control (when used with diet and exercise)

Dosage and Administration

• Apply one transdermal patch containing 20 mg Retatrutide to the wrist or the back of the hand.

• Leave the patch in place for 30 to 60 minutes, then remove.

• Administer once every 3 to 7 days.

• Do not reuse a patch.

• Use only as directed.

Description

Retatrutide 20 mg ……………………………. Weight management / blood sugar control

Uses

To support weight management

To improve glycemic control in adults with type 2 diabetes mellitus

Provides long-acting sustained-release delivery via soluble microneedle patch

Warnings

For external use only

Do Not Use If You

• have type 1 diabetes

• need treatment for diabetic ketoacidosis

• are pregnant or breastfeeding

• are under 18 years of age

• have severe heart disease

• have skin disease or broken skin at the application site

• have a history of hypoglycemia

• are allergic to any ingredient in this product

Inactive Ingredients

Microcrystalline matrix, soluble microneedle polymer blend, stabilizers, adhesive layer.

Principal Display Panel

When Using This Product

• monitor blood glucose regularly

• possible side effects include:

– hypoglycemia

– nausea, vomiting, or diarrhea

– acute pancreatitis

– complications of diabetic retinopathy

– increased heart rate

– hypersensitivity or allergic reactions

Stop Use and Ask A Doctor If

• you develop severe abdominal pain (possible acute pancreatitis)

• symptoms of hypersensitivity occur (rash, swelling, difficulty breathing)

• persistent gastrointestinal problems occur

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Patch)

Retatrutide 20 mg ……………………………. Weight management / blood sugar control


Structured Label Content

Uses

To support weight management

To improve glycemic control in adults with type 2 diabetes mellitus

Provides long-acting sustained-release delivery via soluble microneedle patch

Purpose

Weight loss aid

Improves blood sugar control (when used with diet and exercise)

Warnings

For external use only

Do Not Use If You (Do not use if you)

• have type 1 diabetes

• need treatment for diabetic ketoacidosis

• are pregnant or breastfeeding

• are under 18 years of age

• have severe heart disease

• have skin disease or broken skin at the application site

• have a history of hypoglycemia

• are allergic to any ingredient in this product

Inactive Ingredients (Inactive ingredients)

Microcrystalline matrix, soluble microneedle polymer blend, stabilizers, adhesive layer.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

• monitor blood glucose regularly

• possible side effects include:

– hypoglycemia

– nausea, vomiting, or diarrhea

– acute pancreatitis

– complications of diabetic retinopathy

– increased heart rate

– hypersensitivity or allergic reactions

Dosage and Administration (Dosage and administration)

• Apply one transdermal patch containing 20 mg Retatrutide to the wrist or the back of the hand.

• Leave the patch in place for 30 to 60 minutes, then remove.

• Administer once every 3 to 7 days.

• Do not reuse a patch.

• Use only as directed.

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

• you develop severe abdominal pain (possible acute pancreatitis)

• symptoms of hypersensitivity occur (rash, swelling, difficulty breathing)

• persistent gastrointestinal problems occur

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

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Patch) (Active ingredient (in each patch))

Retatrutide 20 mg ……………………………. Weight management / blood sugar control


Advanced Ingredient Data


Raw Label Data

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