FDA.reportPublic FDA data

HillVital MASTERBALM PAIN RELIEVING LOTION

Manufacturer
Biomaster-agro Kereskedelmi Es Szolgaltato Korlatolt Felelossegu Tarsasag
Effective date
2016-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:06

Label at a glance#

ProductMasterbalm
Active ingredientCAMPHOR (NATURAL)
Label structure11 sections

Dosage and administration

• clean affected area before applying product • adults and children 2 years of age and older: apply  to affected area not more than 3 to 4 times daily. • children under 2 years of age: ask a doctor  

Storage and handling

• store at room temperature 59°F-77ºF • keep lid tightly close • do not use, pour, spill or store near heat source or open flame  • do not refrigerate

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.70%

Purpose

OTC - PURPOSE SECTION

External analgesic

INDICATIONS & USAGE SECTION

Uses: For the temporarily relief of pain and itching associated with:

• minor burn, sunburn • minor cuts, scrapes, insect bites 

• minor skin problems. 

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• clean affected area before applying product • adults and children 2 years of age and older: apply  to affected area not more than 3 to 4 times daily. • children under 2 years of age: ask a doctor  

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

• store at room temperature 59°F-77ºF • keep lid tightly close • do not use, pour, spill or store near heat source or open flame • do not refrigerate

OTC - QUESTIONS SECTION

Questions? Call 239 938 4116
(Monday- Friday, 9 AM- 4PM)
Or write us at: info@hillvitalusa.com

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MasterBalm-2MasterBalm-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1809842camphor 0.7 % Topical LotionPSN2
1809842camphor 7 MG/ML Topical LotionSCD2
1809842camphor 0.7 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70823-101-252020-01-31C16284748780-19d75b9d0-a555-f424-e053-dadaa90a57ceHillVital MASTERBALM PAIN RELIEVING LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70823-101-25Masterbalm250 mL in 1 BOTTLELOTION2502
70823-101-25Masterbalm1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70823-101MASTERBALM (CAMPHOR) LOTION [BIOMASTER-AGRO KERESKEDELMI ES SZOLGALTATO KORLATOLT FELELOSSEGU TARSASAG]2Legacy NDC, 2 package rows20160915_2cccc07a-80f3-4de4-b31a-87aba0c11e42.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70823-10170823-101-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
JUNIPERUS OXYCEDRUS LEAF OILYNW2QPG8YKIACT
THYME OIL2UK410MY6BIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
HORSE CHESTNUT3C18L6RJAZIACT
SORBITAN6O92ICV9RUIACT
PROPANEDIOL5965N8W85TIACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM ACRYLATE7C98FKB43HIACT
BEHENETH-250G17KJ5M7PIACT
BEHENETH-25 METHACRYLATE108R05PWG6IACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
PEPPERMINT OILAV092KU4JHIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
CALENDULA OFFICINALIS SEED OIL9JS8DS42SVIACT
ROSEMARY OIL8LGU7VM393IACT
PINUS SYLVESTRIS SPROUT5M5LA1PB91IACT
TURMERIC856YO1Z64FIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
66989f80-e8b6-4af5-997c-5546ea4cc3d62cccc07a-80f3-4de4-b31a-87aba0c11e422016-09-15WarningsExact identifier
spl id: 66989f80-e8b6-4af5-997c-5546ea4cc3d6
spl set id: 2cccc07a-80f3-4de4-b31a-87aba0c11e42

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.