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Controlling balm with tea tree oil

Medically reviewed on November 2, 2017

Dosage form: emulsion
Ingredients: SALICYLIC ACID 0.24mg in 29.6mg
Labeler: CA-BOTANA INTERNATIONAL
NDC Code: 35192-016

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.

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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Package Label Display Panel
CONTROLLING BALM WITH TEA TREE OIL 
salicylic acid emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.24 mg  in 29.6 mg
Inactive Ingredients
Ingredient NameStrength
GLATIRAMER ACETATE 
ALOE VERA LEAF 
COPPER 
ARGANIA SPINOSA LEAF 
.ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOL 
CAMELLIA SINENSIS FLOWER 
CHAMOMILE 
CINNAMON 
LEMON OIL 
COPPER GLUCONATE 
ALCOHOL 
ETHYLHEXYLGLYCERIN 
ACAI 
GINKGO 
GLYCINE 
HAMAMELIS VIRGINIANA BARK 
HYPERICUM PERFORATUM 
JUNIPER BERRY OIL 
LACTIC ACID 
LAVENDER OIL 
MALPIGHIA EMARGINATA SEED 
MELALEUCA ALTERNIFOLIA LEAF 
OLEA EUROPAEA LEAF 
PHENOXYETHANOL 
PINUS TAEDA BARK 
POLYSORBATE 20 
POTASSIUM SORBATE 
PUNICA GRANATUM FLOWER 
ROSA CANINA FLOWER 
ROSEMARY 
SODIUM HYDROXIDE 
VITIS VINIFERA FLOWERING TOP 
WATER 
XANTHAN GUM 
SODIUM PYRROLIDONE CARBOXYLATE 
HYALURONATE SODIUM 
PROPYLENE GLYCOL, (R)- 
1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE 
Packaging
#Item CodePackage Description
1NDC:35192-016-0529.4 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/09/2014
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIOperations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-016)

 
CA-BOTANA INTERNATIONAL

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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