Organic Tea Tree Treatment Gel

ORGANIC TEA TREE TREATMENT GEL- salicylic acid 2% gel gel
HERRCO COSMETICS LIMITED

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.

----------

Salicylic Acid 2%

For the treatment of acne

Keep out of reach of children.

Acne Treatment

Tea Gel

ORGANIC TEA TREE TREATMENT GEL
salicylic acid 2% gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71643-1019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BILBERRY (UNII: 9P2U39H18W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUGARCANE (UNII: 81H2R5AOH3)
ORANGE (UNII: 5EVU04N5QU)
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
LEMON OIL (UNII: I9GRO824LL)
ROSEMARY OIL (UNII: 8LGU7VM393)
LIME OIL (UNII: UZH29XGA8G)
SALIX ALBA BARK (UNII: 205MXS71H7)
TEA TREE OIL (UNII: VIF565UC2G)
SPEARMINT OIL (UNII: C3M81465G5)
CUCUMBER (UNII: YY7C30VXJT)
CHAMOMILE (UNII: FGL3685T2X)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GRAPEFRUIT PEEL (UNII: 3582N05Q44)
LEMON (UNII: 24RS0A988O)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71643-1019-1	10 mL in 1 BOX; Type 0: Not a Combination Product	09/26/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	09/26/2019

Labeler - HERRCO COSMETICS LIMITED (211536385)

Registrant - HERRCO COSMETICS LIMITED (211536385)