OTC Medication Information: Controlling Balm with Tea Tree Oil

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

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.

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

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CONTROLLING BALM WITH TEA TREE OIL
salicylic acid emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1.89 mg in 237 mg
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:35192-018-07 237 mg in 1 BOTTLE None
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 Operations
CA-BOTANA INTERNATIONAL 106276728 manufacture (35192-018)

Revised: 01/2021 CA-BOTANA INTERNATIONAL

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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