BLISTER BALM- menthol 1% salve 
Floratech Botanicals, LLC

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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External analgesic

Active Ingredients

Menthol 1%

Purpose

External Analgesic - cold sore or fever blister treatment

Uses:

For relief of pain and itching associated with cold sore and fever blister outbreaks.

Intense and immediate blocking of cold sore and gever blister symptoms.

Warnings

For external use only.

Keep out of reach of children.

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

keep out of reach of children. If swallowed get medical help or contact a poison control center immediately. (1-800-222-1222)

Stop use and ask doctor if condition worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product avoid contact with the eyes

keep out of Reach of children. If swallowed, get medical help or contact a poison control center immediately. (1-800-222-1222)

Directions

Inactive Ingredients

camphor

clove (syzygium aromaticum) leaf oil

eucalyptus globulus leaf oil

hydrolyzed jojoba esters

isopropyl jojobate

jojoba (simmondsia chinensis) esters

jojoba alcohols

lemon balm (melissa officinalis) oil

peppermint (menthe piperita) oil

rose geranium (pelargonium graveolens) oil

LABEL

BLISTER BALM 
menthol 1% salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70996-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
LEMON BALM OIL (UNII: MJ76269K9S)  
ALPROSTADIL ISOPROPYL ESTER (UNII: 8THV3YDD6A)  
CLOVE LEAF OIL (UNII: VCA5491KVF)  
PELARGONIUM ROSEUM OIL (UNII: XSN2Q85DC6)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70996-003-012.6 g in 1 TUBE; Type 0: Not a Combination Product12/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/21/2016
Labeler - Floratech Botanicals, LLC (805985686)

Revised: 11/2018
Document Id: 4ec00f03-53a9-42c6-b844-abe00bc60af4
Set id: 442e8091-cbf6-4c61-e054-00144ff8d46c
Version: 2
Effective Time: 20181106
 
Floratech Botanicals, LLC