SPL v1
SPL
SPL Set ID 3d18a8a9-68a4-1406-e063-6294a90a225c
Route
TOPICAL
Published
Effective Date 2025-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Retatrutide 1.6 mg ……………………………. Weight management / blood sugar control

Purpose

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

Dosage and Administration

For external use only.


Medication Information

Purpose

Weight loss aid

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

Dosage and Administration

For external use only.

Description

Retatrutide 1.6 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

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 1.6 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

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)

For external use only.

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 1.6 mg ……………………………. Weight management / blood sugar control


Advanced Ingredient Data


Raw Label Data

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