IMAGE SKINCARE CLEAR CELL CLARIFYING ACNE SPOT TREATMENT- salicylic acid gel 
Natural Technology, LLC

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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Salicylic Acid 2%. Purpose: Acne Treatment

CC14g - Active Ingredient14g. NDC: 79458-002-00

Purpose: Acne Treatment

CC 14g - Purpose14 g. NDC: 79458-002-00

For external use only

CC 14g - Warnings14 g. NDC: 79458-002-00

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

CC 14g - When Using14 g. NDC: 79458-002-00

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

CC 14g - Keep Out of Reach of Children14g. NDC: 79458-002-00

- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day

CC 14g - Dosage14 g. NDC: 79458-002-00

Sensitivity Test for a New User.
Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions stated above.

CC 14g - Indications14 g. NDC: 79458-002-00

Store at room temperature.

CC 14g - Storage14 g. NDC: 79458-002-00

Aqua/Water/EAU, Propanediol, Butylene Glycol, Polyacrylate Crosspolymer-6, Glycerin, Dimethyl Isosorbide, Zinc PCA, Sodium Hydroxide, Maris Aqua/Sea Water, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tasmannia Lanceolata Fruit/Leaf Extract, Cinnamomum Cassia Bark Extract, Sanguisorba Officinalis Root Extract, Zingiber Officinale (Ginger) Root Extract, Laminaria Digitata Extract, Phenoxyethanol, Chlorella Vulgaris Extract, Saccharide Isomerate, Cinnamal, Limonene, Ethylhexylglycerin.

CC 14g - Inactive Ingredients14 g. NDC: 79458-002-00

Clear Cell clarifying acne spot treatment

CC 14g - Principal Display14g. NDC: 79458-002-00

IMAGE SKINCARE CLEAR CELL CLARIFYING ACNE SPOT TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79458-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TASMANNIA LANCEOLATA LEAF (UNII: H8C2R3TXSF)  
WATER (UNII: 059QF0KO0R)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
TEA TREE OIL (UNII: VIF565UC2G)  
TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)  
CHINESE CINNAMON (UNII: WS4CQ062KM)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
GINGER (UNII: C5529G5JPQ)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CINNAMALDEHYDE (UNII: SR60A3XG0F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPANEDIOL (UNII: 5965N8W85T)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79458-002-011 in 1 BOX03/17/2022
1NDC:79458-002-0014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/17/2022
Labeler - Natural Technology, LLC (618561906)

Revised: 3/2022
Document Id: d7f8fb94-0be2-686c-e053-2995a90a3c99
Set id: d7f8fb94-0be1-686c-e053-2995a90a3c99
Version: 1
Effective Time: 20220317
 
Natural Technology, LLC