ACNE FORMULA by Volans Epic LLC / PONTIKA AEROTECH LIMITED ACNE FORMULA cream

ACNE FORMULA by

Drug Labeling and Warnings

ACNE FORMULA by is a Otc medication manufactured, distributed, or labeled by Volans Epic LLC, PONTIKA AEROTECH LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients Purpose

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

Warnings

FOR EXTERNAL USEONLY.

When using this product

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

KEEP OUT OF REACH OF CHILDREN

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

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: info@majesticpure.com or call us on +1 530-464-6426

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE FORMULA 
acne formula cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83325-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 g  in 50 g
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	0.05 g  in 50 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 50 g
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	0.5 g  in 50 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
TALC (UNII: 7SEV7J4R1U)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
ISODODECANE (UNII: A8289P68Y2)
C13-15 ALKANE (UNII: 114P5I43UJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FRAGRANCE 13576 (UNII: 5EM498GW35)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83325-004-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/02/2024

Labeler - Volans Epic LLC (118944905)

Establishment
Name	Address	ID/FEI	Business Operations
PONTIKA AEROTECH LIMITED		861299010	manufacture(83325-004) , analysis(83325-004)