5 In 1

5 In 1
SPL v1
SPL
SPL Set ID d2db13e4-34e3-4906-89a8-1e1ef9302b50
Route
TOPICAL
Published
Effective Date 2024-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.5 g) Hyaluronic Acid (0.05 g) Niacinamide (2 g) Zinc Cation (0.5 g) Menthol (0.03 g)
Inactive Ingredients
Water Dipropylene Glycol Sodium Acrylate Glyceryl Stearate/peg-100 Stearate Talc Hydroxypropyl Corn Starch (5% Substitution By Weight) Isododecane C13-15 Alkane Titanium Dioxide Phenoxyethanol Sodium Hydroxide Hydroxymethyl Cellulose Citric Acid Monohydrate Fragrance 13576 Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-02

Description

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne

Purpose

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne


Medication Information

Purpose

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne

Description

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne

Use

For the treatment of acne

Section 42229-5

DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS:

Volans Epic LLC

Corporation Trust Center, 1209 Orange Street, Wilmington,

Delaware 19801, Country of New Castle

MANUFACTURED BY:

Pontika Aerotech Limited

Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District

Sirmour, Himachal Pradesh-173001, India

Mfg.Lic.No.:N-COS/18/47

Made in India

Section 50565-1

Keep out of reach of children.If swallowed, get medical help.

Patch Test Recommended.

Warnings

FOR EXTERNAL USEONLY.

Directions

Wash your face with a cleanser. Use a pea-sized amount to dot the 5 in 1 Acne Formula Face Moisturizer on your cheeks, forehead, nose and under-eye. Gently massage it into your skin.

Other Lnformation

Store in a cool & dry place. Keep away from direct sunlight.

Inactive Ingredients

Purified Water, Dipropylene Glycol, Sodium Acrylates Copolymer and Lecithin, PEG-100 Stearate and Glyceryl Stearate, Purified Talc, Hydroxypropyl Starch Phosphate, Isododecane, C13-15 Alkane, Titanium Dioxide, Phenoxyethanol, Sodium Hydroxide, Hydroxyethyl cellulose, Citric Acid Monohydrate, Fragrance, Tetra Sodium EDTA

Questions Or Comments?

For any customer feedback or queries,

write to us at: [email protected] or call us on +1 530-464-6426

Principal Display Panel

When Using This Product

■ Avoid contact with eyes. If contact occurs, flush thoroughly with water

Active Ingredients Purpose

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne


Structured Label Content

Use

For the treatment of acne

Section 42229-5 (42229-5)

DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS:

Volans Epic LLC

Corporation Trust Center, 1209 Orange Street, Wilmington,

Delaware 19801, Country of New Castle

MANUFACTURED BY:

Pontika Aerotech Limited

Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District

Sirmour, Himachal Pradesh-173001, India

Mfg.Lic.No.:N-COS/18/47

Made in India

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help.

Patch Test Recommended.

Warnings

FOR EXTERNAL USEONLY.

Directions (DIRECTIONS)

Wash your face with a cleanser. Use a pea-sized amount to dot the 5 in 1 Acne Formula Face Moisturizer on your cheeks, forehead, nose and under-eye. Gently massage it into your skin.

Other Lnformation (Other lnformation)

Store in a cool & dry place. Keep away from direct sunlight.

Inactive Ingredients

Purified Water, Dipropylene Glycol, Sodium Acrylates Copolymer and Lecithin, PEG-100 Stearate and Glyceryl Stearate, Purified Talc, Hydroxypropyl Starch Phosphate, Isododecane, C13-15 Alkane, Titanium Dioxide, Phenoxyethanol, Sodium Hydroxide, Hydroxyethyl cellulose, Citric Acid Monohydrate, Fragrance, Tetra Sodium EDTA

Questions Or Comments? (Questions or Comments?)

For any customer feedback or queries,

write to us at: [email protected] or call us on +1 530-464-6426

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

■ Avoid contact with eyes. If contact occurs, flush thoroughly with water

Active Ingredients Purpose

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne


Advanced Ingredient Data


Raw Label Data

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