Hello Unicorn Splash Mouthwash
FDA Label NDC 35000-687

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colgate-palmolive Company for the product Hello Unicorn Splash (NDC 35000-687). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by Hello Products LLC
Montclair, NJ 07042

Active Ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • Use once a day after brushing your teeth with a toothpaste
  • vigorously swith 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

    • Children under 6 years of age: consult a dentist or doctor

Other Information

  • store at room temperature
  • do not use if printed band around cap is broken or missing

Inactive Ingredients

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid

Questions?

1-855-444-3556

Principal Display Panel - 473 Ml Bottle Label

naturally
friendly™
hello®

unicorn splash
anticavity fluoride rinse

bubble gum
natural flavor

prevents cavities
no alcohol
strengthens teeth

tastes magical
works brilliantly

no artificial sweeteners. no dyes.
no SLS/sulfates. no brainer.

16 FL OZ (1 PT) 473 mL

44917

Principal Display Panel (473 mL Bottle Label)

Principal Display Panel (473 mL Bottle Label)

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