Label: CVS SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL- oxymetazoline hydrochloride spray
- NDC Code(s): 69842-614-22
- Packager: CVS PHARMACY, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 14, 2023
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
When using this product
- do not exceed recommended dosage
- do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
- this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
- the use of this container by more than one person may spread infection
- adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
- children under 6 years of age: consult a doctor.
Shake well before use.
To open: Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using for the first time, prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.
DO NOT DISCARD CAP.
- Other information
- Inactive ingredients
PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
*Compare to the active ingredient in Mucinex® SINUS-MAX® CLEAR & COOL Nasal Spray
Oxymetazoline HCl 0.05%
SEVERE NASAL CONGESTION RELIEF
CLEAR & COOL
- Fast acting
- Lasts 12 Hours
- Cooling Menthol
3/4 FL OZ (22 mL)
IMPORTANT: Keep this carton for future reference for full labeling.
INGREDIENTS AND APPEARANCE
CVS SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-614 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (NATURAL) (UNII: N20HL7Q941) edetate disodium (UNII: 7FLD91C86K) eucalyptol (UNII: RV6J6604TK) menthol, unspecified form (UNII: L7T10EIP3A) polysorbate 80 (UNII: 6OZP39ZG8H) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-614-22 1 in 1 CARTON 03/10/2022 1 22 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/10/2022 Labeler - CVS PHARMACY, INC. (062312574)