Label: MASTERBALM- camphor lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70823-101-25 - Packager: Biomaster-agro Kereskedelmi Es Szolgaltato Korlatolt Felelossegu Tarsasag
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 15, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- INDICATIONS & USAGE
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Warnings
For external use only.
Do not use • with other topical pain relievers • with heating pads or heating devices.
When using this product
• do not use in or near eyes • do not apply to wounds or damaged skin • do not bandage tightly
Stop use and ask a doctor if
• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days • redness or irritation develops
If pregnant or breast-feeding ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive ingredients
Aloe vera extract, Arnica Montana extract, Cetyl alcohol, Chamomile extract, Common juniper oil, Common thyme oil, Eucalyptus oil, Glycerin, Horse-chestnut extract, Nipaquard, November EC2, Peppermint oil, Polyglyceryl-3 Stearate/Citrate, Pot marigold oil, Rosemary oil, Scots pine leaf extract, Turmeric extract, Xanthan Gum
- Other information
- QUESTIONS
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SPL UNCLASSIFIED SECTION
Distributed by:
HILLVITAL USA
P.O. Box 152214
Cape Coral, FL., 33915
Made in Hungary
Hillvital Masterbalm is made of essential oils and extracts of 12 powerful medicinal herbs. All active substances have the best quality and are 100% natural. Regular use can help to release or dissolve pains. It can help to soothe musculoskeletal aches.
FREE FROM ARTIFICIAL FRAGRANCES
COLOURINGS AND HARMFUL CHEMICALS
NO KNOWN SIDE EFFECTS
NOT TESTED ON ANIMALS
12 natural herbs
MEDICINAL HERBS
- Packaging
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INGREDIENTS AND APPEARANCE
MASTERBALM
camphor lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70823-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 0.7 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA (UNII: O80TY208ZW) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) JUNIPERUS OXYCEDRUS LEAF OIL (UNII: YNW2QPG8YK) THYME OIL (UNII: 2UK410MY6B) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) HORSE CHESTNUT (UNII: 3C18L6RJAZ) SORBITAN (UNII: 6O92ICV9RU) PROPANEDIOL (UNII: 5965N8W85T) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM ACRYLATE (UNII: 7C98FKB43H) BEHENETH-25 (UNII: 0G17KJ5M7P) BEHENETH-25 METHACRYLATE (UNII: 108R05PWG6) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) PEPPERMINT OIL (UNII: AV092KU4JH) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) ROSEMARY OIL (UNII: 8LGU7VM393) PINUS SYLVESTRIS SPROUT (UNII: 5M5LA1PB91) TURMERIC (UNII: 856YO1Z64F) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70823-101-25 1 in 1 BOX 08/01/2016 1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2016 Labeler - Biomaster-agro Kereskedelmi Es Szolgaltato Korlatolt Felelossegu Tarsasag (401143358) Establishment Name Address ID/FEI Business Operations Biomaster-agro Kereskedelmi Es Szolgaltato Korlatolt Felelossegu Tarsasag 401143358 manufacture(70823-101)
