GMC Medical® Acne-Clear

Drug Labeling and Warnings

Drug Details [pdf]

GMC MEDICAL  ACNE-CLEAR- salicylic acid gel 
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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GMC Medical®
Acne-Clear

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

  • Clears acne blemishes

Warnings

For external use only

When using this product:

  • Do not use near or in the eyes.
  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if:

  • Sensitivity develops or increases
  • Irritation becomes severe

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply and emulsify carefully with wet fingers and rinse thoroughly twice a day, or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce frequency of application.
  • Sensitivity Test for a New User. Apply product sparingly to 1 or 2 small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive ingredients

WATER/EAU, SODIUM LAURYL GLUCOSE CARBOXYLATE, LAURYL GLUCOSIDE, COCO-BETAINE, COCO-GLUCOSIDE, GLYCERYL OLEATE, SODIUM CITRATE, GLYCERIN, PANTHENOL, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, 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, PEUMUS BOLDUS LEAF EXTRACT, BUTYLENE GLYCOL, XANTHAN GUM, ALLANTOIN, PEG-120 METHYL GLUCOSE DIOLEATE

Other information

Store at 59-86°F (15-30°C).

Questions?

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

PRINCIPAL DISPLAY PANEL - 200 ml Pump Bottle Box

GMC MEDICAL®

ACNE-CLEAR

CLEANSING GEL

2%
Salicylic Acid

Acne Treatment

Oily to acne prone skin

Paraben-Free ■ Fragrance-Free

NDC: 64127-135-01

200 ml – 7 fl. oz.

Principal Display Panel - 200 ml Pump Bottle Box
GMC MEDICAL   ACNE-CLEAR
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64127-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid21.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
COCO-BETAINE (UNII: 03DH2IZ3FY)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
SAGE (UNII: 065C5D077J)  
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALLANTOIN (UNII: 344S277G0Z)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64127-135-011 in 1 BOX02/10/201410/05/2015
1200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/10/201410/05/2015
Labeler - Laboratoires dermo Cosmetik Inc (249335480)

Revised: 1/2019
Document Id: ef458942-4fe9-494e-8a18-5fb1d0ecf3ee
Set id: d7bc10cb-75f0-47d1-84b9-52c2539a4938
Version: 2
Effective Time: 20190109