ORGANIC TEA TREE TREATMENT GEL- salicylic acid 2% gel gel

Organic Tea Tree Treatment Gel by

Drug Labeling and Warnings

Organic Tea Tree Treatment Gel by is a Otc medication manufactured, distributed, or labeled by HERRCO COSMETICS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 2%​

INDICATIONS & USAGE

For the treatment of acne​

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

WARNINGS

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.​

PURPOSE

Acne Treatment

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - HERRCO COSMETICS LIMITED (211536385)

Registrant - HERRCO COSMETICS LIMITED (211536385)