FDA.reportPublic FDA data

Natural Relief 1222

Manufacturer
RENU LABORATORIES, INC.
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:10

Label at a glance#

ProductNatural Relief 1222
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol. . . . 1.25 percent

WARNINGS SECTION

For external use only Avoid contact with eyes and sensitive areas. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists for more than 3 days or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age and older - apply liberally to affected area

  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary

OTHER SAFETY INFORMATION

Store at 68 ° to 77° F.

STATEMENT OF IDENTITY SECTION

Natural Relief 1222 HOMEOPATHIC JOINT & MUSCLE PAIN RELIEF

INACTIVE INGREDIENT SECTION

Allium Sativum (Garlic) Bulb Extract, Aloe Barbadensis (Aloe) Leaf Extract, Benzoic Acid, Collagen, Dehydroacetic Acid, Deionized Water, Emulsifying Wax NF, Fragrance, Glycine Soja (Soybean) Oil, HPUS Bryonia 10x, HPUS Rhus Toxicodendron 10x, Hydolyzed Elastin (Powder), Mineral Oil, Myristyl Myristate, Phenoxyethanol, Propylene Glycol, USP, Prunus Amygdalus Dulcis (Sweet Almond Oil), Squalane, Stearic Acid, Triethanolamine, Vitamin E dl Alpha Tocopherol

RECENT MAJOR CHANGES SECTION

Added a better explanation of uses 1.22.2024

Directions modified for a better explanation 1.22.2024

OTC - WHEN USING SECTION

When using this product:

  • Do not bandage tightly -
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use heating pads or other heating devices

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, seek medical help or contact a poison control center right away

STATEMENT OF IDENTITY SECTION

Natural Relief 1222

Soothing Joint & Muscle

Pain Relief

Natural Relief 1222 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL ART

NR1222 bottle labelNR1222 bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240896menthol 1.25 % Topical LotionPSN1
240896menthol 12.5 MG/ML Topical LotionSCD1
240896menthol 1.25 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-711-082025-07-29C16284748780-13b156c62-3061-fb37-e063-e6dba90a4e07Natural Relief 1222 Menthol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-711-08Natural Relief 1222224 g in 1 BOTTLE, PUMPLOTION2241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-711NATURAL RELIEF 1222 (MENTHOL) LOTION [RENU LABORATORIES, INC.]11 package rows20240202_0f8e8271-dc6a-90d2-e063-6294a90a325d.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-71176348-711-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GARLICV1V998DC17IACT
TOXICODENDRON PUBESCENS LEAF6IO182RP7AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MYRISTYL MYRISTATE4042ZC00DYIACT
BRYONIA ALBA ROOTT7J046YI2BIACT
SQUALANEGW89575KF9IACT
WHITE WAX7G1J5DA97FIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW)ZR28QKN0WTIACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
MENTHOLL7T10EIP3AACTIB
ALMOND OIL66YXD4DKO9IACT
SOYBEAN OIL241ATL177AIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TETRASODIUM EDETATE DIHYDRATE3JGX4KKZ4AIACT

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
0f8e805b-92ab-901d-e063-6294a90af7b00f8e8271-dc6a-90d2-e063-6294a90a325d2024-01-15WarningsExact identifier
spl id: 0f8e805b-92ab-901d-e063-6294a90af7b0
spl set id: 0f8e8271-dc6a-90d2-e063-6294a90a325d

Reported adverse events (FAERS/openFDA)#

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