FDA.reportPublic FDA data

SierraSil Pain Relief

Manufacturer
O24 Naturals, LLC | D&d Essential Oils, Llc., | Biomed Laboratories LLC
Effective date
2018-02-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 01:03:29

Label at a glance#

ProductSierraSil Pain Relief
Active ingredientCAMPHOR (NATURAL)
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

adults and children 2 yrs of age and older: apply to affected area not more than 3 to 4 times daily. children under 2 yrs of age: consult a doctor.

Storage and handling

shake well before use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Purpose

OTC - PURPOSE SECTION

Camphor 3.1%.........................................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

  • apply to wounds or damaged skin
  • bandage tightly
  • use with a heating pad

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 yrs of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 yrs of age: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • shake well before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Hydrothermal Mineral Complex (SierraSil), Lavandula Angustifolia (Lavender) Oil, Mentha arvensis (Peppermint) Oil, Rosmarinus Officinalis Leaf (Rosemary) Oil

Questions?

OTC - QUESTIONS SECTION

Visit www.sierrasil.com or call toll free 1-877-743-7720 Monday-Friday 8:00am to 4:30pm

DESCRIPTION SECTION

Distributed by SierraSil Health Inc.

1500 NW Bethany Blvd Suite 200,

Beaverton, OR, 97006

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SierraSil

Pain

Relief

TOPICAL

ANALGESIC

SPRAY

TEMPORARILY

RELIEVES

MINOR ACHES

AND PAINS

1 fl oz / 30 mL

SierrasilcartonSierrasilcarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130897871000426GTIN-13: 0897871000426
EAN-13: 0897871000426
GTIN-12: 897871000426
UPC-A: 897871000426
GTIN storage (14 digits): 00897871000426		Sierrasilcarton.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9414
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9414
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6624
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H84
LEMON OILINACTIVE INGREDIENTI9GRO824LL4
MENTHA ARVENSIS FLOWER OILINACTIVE INGREDIENTQ129Z1W6Y24
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B4
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3934

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58265-00258265-002-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ORANGE OILAKN3KSD11BIACT
LEMON OILI9GRO824LLIACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
MENTHA ARVENSIS FLOWER OILQ129Z1W6Y2IACT
ROSEMARY OIL8LGU7VM393IACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BPOWDER, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLSUSPENSION / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BELIXIR / ORAL0.24 mgExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BSUSPENSION / ORAL1 mgExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BLIQUID / ORAL50 mgExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BTABLET, CHEWABLE / ORAL3.7 mgExact identifier — unii candidate
6 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BTABLET / SUBLINGUALNAExact identifier — unii candidate
6 equally ranked IID candidates

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
d113ad13-0a5f-7a1b-e053-2995a90a84e0fb018de5-1bb1-4770-ac5c-7f19f89ec5ff2021-11-18WarningsExact identifier
spl set id: fb018de5-1bb1-4770-ac5c-7f19f89ec5ff

Reported adverse events (FAERS/openFDA)#

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