WATERMELON FROST SORE THROAT - menthol spray 
GUILIN SANJIN PHARMACEUTICAL CO., 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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Drug Facts

Active ingredients
Menthol 2.0%

Purpose
Oral pain reliever

Use
For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

Warnings

Do not use
more than 2 days for use in relieving minor sore throat

Ask a doctor before use if
administering to children under 3 years of age for relief of minor sore throat

When using this product
do not exceed recommended dosage

Stop use and ask a dentist or doctor promptly if
sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
sore throat is severe or persists for more than 2 days
sore throat accompanied or followed by
    fever  headache  rash  swelling  nausea  vomiting
(these could be signs of a serious condition)

Keep out of reach of children.
If more than used for irritation or pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 3 and years of age and older:  
Remove purple ring located between the bottle cap and the dispensing unit. Retain ring.
Rotate the dispensing tube up.
Press down on cap to spray affected area.
Gargle, swish around, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age should be supervised in the use of this product.

children under 3 years of age:
if for use in relieving minor sore throat consult a doctor, for other uses see directions for adults

children under 2 years of age:
consult a dentist or doctor

Other information
after use, replace the purple ring to prevent unintentional dispensing of product.
store at 15º to 30º C (59º to 86º F)

Inactive ingredients
Alcohol,
baikal skullcap (huang-qin) root,
belamcanda [Belamcanda chinensis (L.) DC.] rhizome,
dwarf-lilyturf (mai-dong) root,
fang feng root,
honeysuckle [Lonicera macranthoides Hand. Mazz] flower,
licorice (Glycyrrhiza uralensis Fisch. Ex DC) root and rhizome,
polysorbate 80,
purified water,
scrophularia (Scrophularia ningpoensis Hemsl.) root,
sodium borate,
steviosin,
Vietnamese sophora (Sophora tonkinensis Gagnep.) root and rhizome,
and watermelon [Citrullus lanatus (Thunb.) Matsum Nakai] fruit.

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number

WATERMELON FROST SORE THROAT SPRAY

NDC-62785-001-01

ORAL PAIN RELIEVER

MENTHOL 2%

20 ML (0.68 FL OZ)IMAGE OF CARTON

WATERMELON FROST SORE THROAT  
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62785-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
IRIS DOMESTICA WHOLE (UNII: 9IJ63JIC40)  
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
LONICERA CONFUSA FLOWER (UNII: 3JV904IJ0V)  
LICORICE (UNII: 61ZBX54883)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
SOPHORA TONKINENSIS WHOLE (UNII: WL8G39B4EA)  
WATERMELON (UNII: 231473QB6R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62785-001-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/201403/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/28/201403/21/2018
Labeler - GUILIN SANJIN PHARMACEUTICAL CO., LTD. (528566854)

Revised: 3/2018
 
GUILIN SANJIN PHARMACEUTICAL CO., LTD.