Active Ingredients
Camphor 3%
Menthol 10%
Methyl Salicylate 25%
Newbury Blue Pain Balm
FDA Label NDC 83501-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newbury Extracts, Llc for the product Newbury Blue Pain Balm (NDC 83501-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, stop use and ask a doctor if:, other information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TOPICAL ANESTHETIC
Uses
FOR RELIEF FROM ACHES, ARTHRITIS, MUSCLE SPASMS, AND OVERALL NECK AND BACK PAIN.
Warnings
FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Stop Use And Ask A Doctor If:
- AN ALLERGIC REACTION OCCURS
- REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS BEGIN.
- THE CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
Other Information
STORE BETWEEN 15-30°C (59-86°F). AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F).
Directions
APPLY BALM LIBERALLY AND GENTLY MASSAGE THE AFFECTED AREA. MASSAGE UNTIL ABSORBED INTO SKIN. WASH HANDS WITH WATER AND SOAP AFTER APPLICATION AND AVOID CONTACT WITH EYES. CHILDREN UNDER 18 YEARS OF AGE SHOULD CONSULT A PHYSICIAN BEFORE USE.
Inactive Ingredients
ALOE BARBADENSIS FLOWER EXTRACT, AMPELOPSIS JAPONICA ROOT EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ANGELICA PUBESCENS ROOT EXTRACT, BEESWAX (CERA ALBA), BOSWELLIA CARTERII RESIN EXTRACT, CAMPHOR, CANOLA OIL, CINNAMOMUM CASSIA BARK EXTRACT, COCCINIA INDICA (IVY GOURD) FRUIT EXTRACT, CORALLINA OFFICINALIS (SEAWEED) EXTRACT, CURCUMA LONGA ROOT EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, EUPHORBIA CERIFERA (CANDELILLA WAX) CERA, GLYCYRRHIZA URALENSIS ROOT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, MELIA AZADIRACHTA FLOWER EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, METHYL SALICYLATE, OCIMUM BASILICUM (BASIL) FLOWER/LEAF EXTRACT, OCIMUM SANCTUM (TULSI) LEAF EXTRACT, OLYHYDROXYSTEARIC ACID, REHMANNIA GLUTINOSA ROOT EXTRACT, RICINUS COMMUNIS (CASTOR) SEED OIL, SCROPHULARIA NODOSA EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, TOCOPHERYL ACETATE
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