CONTROLLING BALM WITH TEA TREE OIL- salicylic acid emulsion

Controlling balm with tea tree oil by

Drug Labeling and Warnings

Controlling balm with tea tree oil by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, RODOLFO UGELSTAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Warnings:

For external use only.
Do not use on wounds or damaged skin
When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
Store at room temperature. Lot number and expiration date see crimp or see box.

DOSAGE & ADMINISTRATION

cleanse the skin thoroughly with soft foam deep cleanse before applying. cover the entire affected aread with a thin layer 1 to 2 times daily. because too much drying of the skin may occure, start with 1 application daily, then gradually increase to 2 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.

INACTIVE INGREDIENT

Acrilates/Acrylamine Copolymer

Aloe barbadensis (Aloe vera) extract

Alpha Copper Tripeptide-4 TM

Argania Spinosa (Argan) extract

Benzyl Alcohol

Camellia sinensis (White tea) extract

Chamomilla recutita (Chamomile) extract

Cinnamomum Zeylanicum

Citrus medica lemonum (Lemon)Peel Oil

Copper Gluconate

Ethanol

Ethylhexylglycerin

Euterpe oleracea (Acai) extract

Gingko Biloba extract

Glycine

Hamamelis virginiana (Witchhazel) extract

Hypericum perforatum (St John's wort) extract

Juniperus communis (Juniper) extract

Lactic acid

Lavandula angustifolia oil

Malpighia glabra (Acerola) extract

Melaleuca Alternifolia (Tea tree) leaf oil

Olea europaea (Olive) leaf extract

Phenoxyethanol

Phosphatidylcholine

Pinus Taeda (Pine tree) extract

Polysorbate 20

Potassium Sorbate

Propanediol

Punica granatum (Pomegranate) extract

Rosa canina extract

Rosmarinus officinalis (Rosemary) extract

Sodium Hyaluronate

Sodium Hydroxide

Sodium PC

Tetra sodium

Vitis Vinifera ( Grape) extract

Water (Aqua)

Xanthan Gum

ACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

INDICATIONS & USAGE

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PURPOSE

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PRINCIPAL DISPLAY PANEL

Package Label Display Panel

INGREDIENTS AND APPEARANCE

CONTROLLING BALM WITH TEA TREE OIL 
salicylic acid emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.24 mg  in 29.6 mg

Inactive Ingredients
Ingredient Name	Strength
GLATIRAMER ACETATE (UNII: 5M691HL4BO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COPPER (UNII: 789U1901C5)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
.ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOL (UNII: JE030BGE05)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CHAMOMILE (UNII: FGL3685T2X)
CINNAMON (UNII: 5S29HWU6QB)
LEMON OIL (UNII: I9GRO824LL)
COPPER GLUCONATE (UNII: RV823G6G67)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI (UNII: 46AM2VJ0AW)
GINKGO (UNII: 19FUJ2C58T)
GLYCINE (UNII: TE7660XO1C)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
LACTIC ACID (UNII: 33X04XA5AT)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PINUS TAEDA BARK (UNII: 9I1F994SVG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q)
ROSEMARY (UNII: IJ67X351P9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
VITIS VINIFERA FLOWERING TOP (UNII: 6TG3V35HTV)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)
1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: H026DM5V6U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-016-05	29.4 mg in 1 TUBE; Type 0: Not a Combination Product	11/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/09/2014

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture(35192-016)