Beyond Rapid Relief by Sci-chem International Pty Ltd Beyond Rapid Relief

Beyond Rapid Relief by

Drug Labeling and Warnings

Beyond Rapid Relief by is a Otc medication manufactured, distributed, or labeled by Sci-chem International Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BEYOND RAPID RELIEF- camphor (natural), glycerin cream 
Sci-chem International Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Beyond Rapid Relief

Drug Facts

Active ingredients

Camphor 3%

Glycerin 30%

Purpose

Fever blister/cold sore treatment 

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. 

Warnings

For external use only

When using this product

• do not get into eyes

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

Keep out of reach of children. 

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

Directions

• 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

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

Inactive ingredients

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?

(212) 739-0428

Package labeling: 57261-000-01

BEYOND RAPID RELIEF 
camphor (natural), glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57261-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	30 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	300 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57261-000-01	1 in 1 CARTON	12/01/2022	05/30/2023
1		4 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	10/20/2022	05/30/2023

Labeler - Sci-chem International Pty Ltd (753878391)

Registrant - Sci-chem International Pty Ltd (753878391)

Revised: 5/2023

Document Id: fbbda876-e611-0868-e053-6294a90adaf2

34390-5

Set id: e6f998da-65b2-41cd-9783-73514d7aed5f

Version: 3

Effective Time: 20230515