FDA.reportPublic FDA data

Beyond Rapid Relief

Manufacturer
Sci-chem International Pty Ltd
Effective date
2023-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:31:26

Label at a glance#

ProductBeyond Rapid Relief
Active ingredientCAMPHOR (NATURAL), GLYCERIN
Label structure9 sections

Indications and uses

Relieves dryness and softens cold sores and fever blisters Softens crusts (scabs) associated with cold sores and fever blisters.  For the temporary relief of pain and itching associated with fever blisters and cold sores. 

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 1 to 2 times per cluster of outbreak. Children 2 to 12 years use under adult supervision only. Children under 2 years of age: consult a doctor. In typical cases, apply thoroughly using sterile applicators as directed. If pain persists, apply again after 8-12 hours. In severe cases, apply thoroughly to all outbreaks twice a day for 2...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Glycerin 30%

Purpose

OTC - PURPOSE SECTION

Fever blister/cold sore treatment 

Uses

INDICATIONS & USAGE SECTION

  • Relieves dryness and softens cold sores and fever blisters
  • Softens crusts (scabs) associated with cold sores and fever blisters. 
  • For the temporary relief of pain and itching associated with fever blisters and cold sores. 

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: apply to affected area not more than 1 to 2 times per cluster of outbreak. Children 2 to 12 years use under adult supervision only.
  • Children under 2 years of age: consult a doctor.
  • In typical cases, apply thoroughly using sterile applicators as directed. If pain persists, apply again after 8-12 hours.
  • In severe cases, apply thoroughly to all outbreaks twice a day for 2 days or as required until pain subsides.

Other information

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR IF TUBE IS OPENED OR LEAKING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calendula ( Calendula officinalis) 1:2 flower extract, cetomacrogol 1000, cetostearyl alcohol, cupric sulfate pentahydrate, paraffin oil, purified water, St. John's wort ( Hypericum perforatum) 1:2 flower extract. 

Questions or Comments?

OTC - QUESTIONS SECTION

(212) 739-0428

Package labeling: 57261-000-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

beyond rapid relief outer label 1beyond rapid relief outer label 1beyond rapid relief outer label 2beyond rapid relief outer label 2beyond rapid relief inner labelbeyond rapid relief inner label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57261-00057261-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CUPRIC SULFATELRX7AJ16DTIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
GLYCERINPDC6A3C0OXACTIB

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
fbbda876-e611-0868-e053-6294a90adaf2e6f998da-65b2-41cd-9783-73514d7aed5f2023-05-15WarningsExact identifier
spl id: fbbda876-e611-0868-e053-6294a90adaf2
spl set id: e6f998da-65b2-41cd-9783-73514d7aed5f

Reported adverse events (FAERS/openFDA)#

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