SPL v1
SPL
SPL Set ID 37fce9e6-adae-af3c-e063-6394a90a140b
Route
TOPICAL
Published
Effective Date 2025-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe Vera Leaf Juice (13 g) Menthol (0.4 g)
Inactive Ingredients
Chamomile Coconut Oil Hyaluronic Acid Grape Seed Extract Rosa Canina Seed Oil Tocopherol Candelilla Wax Jojoba Oil Cinnamon Oil Vanilla

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-21

Description

Menthol (from Peppermint Oil) 0.4% Aloe Vera Gel 13%


Medication Information

Warnings and Precautions

If allergic to mint, cinnamon, or botanical oils,On bleeding or infected lip areas,In children under 2 years

Indications and Usage

Reduce Lip Lines

Relieve & Repair

Increase Elasticity

Lip Plumping

Brightening

Dosage and Administration



Apply thin layer to clean lips using fingertip Gently massage for 30 seconds to enhance absorption Use up to 4 times daily, preferably at bedtime For overnight repair: Apply thick layer before sleep

Description

Menthol (from Peppermint Oil) 0.4% Aloe Vera Gel 13%

Section 43683-2

Reduce Lip Lines

Relieve & Repair

Increase Elasticity

Lip Plumping

Brightening

Section 44425-7

Keep tightly closed at 15-30°C (59-86°F). Avoid heat above 40°C (104°F) and direct sunlight.

Section 50565-1

If ingested, contact Poison Control Center

Section 50566-9

If allergic to mint, cinnamon, or botanical oils

On bleeding or infected lip areas

In children under 2 years

Section 50567-7



Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Discontinue if burning sensation persists over 10 minutes

Not for ingestion. If swallowed, seek medical help immediately

Section 51727-6

Candelilla Wax, Coconut Oil, Chamomile Extract, Cinnamon Oil, ROSA CANINA SEED OIL, Hyaluronic Acid, Jojoba Oil, Tocopherol, Vanilla Extract, Grapeseed Extract

Section 55105-1



Temporarily relieves pain from chapped lips,Forms a protective barrier to heal dry/cracked lips,Enhances lip elasticity and reduces visible wrinkles,Brightens lip tone and evens pigmentation

Pxckage Label

Active Ingeredient Section

Menthol (from Peppermint Oil) 0.4%

Aloe Vera Gel 13%


Structured Label Content

Indications and Usage (34067-9)

Reduce Lip Lines

Relieve & Repair

Increase Elasticity

Lip Plumping

Brightening

Dosage and Administration (34068-7)



Apply thin layer to clean lips using fingertip Gently massage for 30 seconds to enhance absorption Use up to 4 times daily, preferably at bedtime For overnight repair: Apply thick layer before sleep

Warnings and Precautions (34071-1)

If allergic to mint, cinnamon, or botanical oils,On bleeding or infected lip areas,In children under 2 years

Section 43683-2 (43683-2)

Reduce Lip Lines

Relieve & Repair

Increase Elasticity

Lip Plumping

Brightening

Section 44425-7 (44425-7)

Keep tightly closed at 15-30°C (59-86°F). Avoid heat above 40°C (104°F) and direct sunlight.

Section 50565-1 (50565-1)

If ingested, contact Poison Control Center

Section 50566-9 (50566-9)

If allergic to mint, cinnamon, or botanical oils

On bleeding or infected lip areas

In children under 2 years

Section 50567-7 (50567-7)



Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Discontinue if burning sensation persists over 10 minutes

Not for ingestion. If swallowed, seek medical help immediately

Section 51727-6 (51727-6)

Candelilla Wax, Coconut Oil, Chamomile Extract, Cinnamon Oil, ROSA CANINA SEED OIL, Hyaluronic Acid, Jojoba Oil, Tocopherol, Vanilla Extract, Grapeseed Extract

Section 55105-1 (55105-1)



Temporarily relieves pain from chapped lips,Forms a protective barrier to heal dry/cracked lips,Enhances lip elasticity and reduces visible wrinkles,Brightens lip tone and evens pigmentation

Pxckage Label (PXCKAGE LABEL)

Active Ingeredient Section (ACTIVE INGEREDIENT SECTION)

Menthol (from Peppermint Oil) 0.4%

Aloe Vera Gel 13%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)