CONTROLLING BALM WITH TEA TREE OIL- salicylic acid emulsion 
CA-BOTANA INTERNATIONAL

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Controlling Balm with Tea Tree Oil

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.

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.

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


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

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CONTROLLING BALM WITH TEA TREE OIL 
salicylic acid emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.89 mg  in 237 mg
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-018-07237 mg in 1 BOTTLE; Type 0: Not a Combination Product11/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00611/09/2014
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-018)

Revised: 10/2023
Document Id: 07edd14e-53dc-7161-e063-6294a90ad319
Set id: 65d71c3e-30ea-40db-9fdb-5d60c079a37d
Version: 13
Effective Time: 20231017
 
CA-BOTANA INTERNATIONAL