XLEAR COUGH DROPS (HONEY LEMON)- menthol lozenge 
Xlear Inc.

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.

----------

Xlear Cough Drops (Honey Lemon)

4.0 mg of Menthol (per drop)

Cough Suppressant / Oral Anesthetic

Temporarily soothes an irritated or sore throat

Adults and children over five - Slowly dissolve one drop every two hours as needed or as directed by a physician. Children under five - Consult your physician.

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore throat symptoms do not improve in 7 days, see your doctor promptly

Keep out of reach of children.

Allergen Information: Mfg. in a facility that processes dairy, peanut, almond, walnut, nutmeg, pecan, and soy protein.

cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water

label

XLEAR COUGH DROPS (HONEY LEMON) 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27017-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 mg
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
ISOMALT (UNII: S870P55O2W)  
HONEY (UNII: Y9H1V576FH)  
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MALIC ACID (UNII: 817L1N4CKP)  
STEVIA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColoryellowScorescore with uneven pieces
ShapeROUNDSize22mm
FlavorHONEY (Lemon) Imprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27017-022-0130 in 1 BOX; Type 0: Not a Combination Product12/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/12/2019
Labeler - Xlear Inc. (839884058)
Establishment
NameAddressID/FEIBusiness Operations
Primrose Candy Company005086855manufacture(27017-022)

Revised: 1/2023
Document Id: f1ec5d88-5cae-5f59-e053-2995a90ae2c8
Set id: 9987a273-e6db-54cd-e053-2a95a90a0aaa
Version: 2
Effective Time: 20230110
 
Xlear Inc.