G.M. COLLIN® ACNE COMPLEX

Drug Labeling and Warnings

Drug Details [pdf]

G.M. COLLIN COMPLEX ACNE- salicylic acid oil 
Laboratoires Dermo Cosmetik Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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G.M. COLLIN®
ACNE COMPLEX

Drug Facts

Active ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

Clears acne blemishes and allows skin to heal.

Warnings

• For External Use Only.

• Do not use in or near the eyes.
• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

• Stop use and ask a doctor if too much skin irritation or sensitivity develops

When using this product and for a week afterwards

• Limit sun exposure
• Use sunscreen

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

After the G.M. Collin cleanser and treating lotion, apply locally using a cotton pad. Morning and/or evening, according to the skin condition or as recommended by your skin care professional. Shake well before use.

Other information

Store in a cool, dry place. Avoid high temperatures. Protect from freezing. Keep away from flame, fire and heat.

Inactive ingredients

WATER/EAU, CITRUS AURANTIUM AMARA (BITTER ORANGE) FLOWER WATER , SD ALCOHOL 3-A, C12-15 ALKYL BENZOATE, PEG-40 CASTOR OIL, CITRUS LIMONUM (LEMON) PEEL OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, CYMBOPOGON NARDUS (CITRONELLA) OIL, MENTHA ARVENSIS LEAF OIL, ABIES SIBIRICA OIL, CINNAMOMUM CAMPHORA OIL, ANIBA ROSAEODORA (ROSEWOOD) WOOD OIL, EUGENIA CARYOPHYLLUS OIL, SODIUM BENZOATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, ETHOXYDIGLYCOL, PEG-8, AMMONIUM HYDROXIDE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ARCTIUM MAJUS ROOT (BURDOCK) EXTRACT, ARNICA MONTANA FLOWER EXTRACT, URTICA DIOICA (NETTLE) EXTRACT, EQUISETIUM ARVENSE (HORSETAIL) EXTRACT, BETULA ALBA LEAF EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, POTASSIUM SORBATE, YELLOW 5, BLUE 1

Questions?

USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PARIS
COLLIN®
G.M.
4

C

COMPLEXE ACNÉ
aux huiles essentielles
ACNE COMPLEX
with essential oils

Peau acnéique, grasse
Acne-Prone, Oily Skin

50 ml - 1.7 fl. oz.

G.M. COLLIN COMPLEX ACNE 
salicylic acid oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
LEMON PEEL (UNII: 72O054U628)
ROSEMARY OIL (UNII: 8LGU7VM393)
CITRONELLA OIL (UNII: QYO8Q067D0)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
CAMPHOR LEAF OIL (UNII: 51D0RGY52V)
ROSEWOOD OIL (UNII: F2522O5L7B)
CLOVE LEAF OIL (UNII: VCA5491KVF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
AMMONIA (UNII: 5138Q19F1X)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
SAGE (UNII: 065C5D077J)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-085-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2011	10/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/25/2011	10/05/2015

Labeler - Laboratoires Dermo Cosmetik Inc. (249335480)

Revised: 1/2019

Document Id: 4403f7c3-619c-4759-93da-d0af98070c9a

34390-5

Set id: f0de8a91-4748-4e7d-91d5-a813d37d4231

Version: 2

Effective Time: 20190109