GLYCERIN: 1,146 Adverse Event Reports & Safety Profile

Carton Labeling - Drug Facts and other Panels (Non-PDP)

Drug Facts

Active ingredient Glycerin 0.4% Purpose: Eye Lubricant Uses: For the temporary relief of burning and irritation due to dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye. Warnings: External Use Only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. If solution changes color or becomes cloudy, do not use. Stop use and ask a doctor If: You experience eye pain, changes in vision, continued redness, or irritation of the eye. Condition worsens or persists for more than 72 hours. Keep out of reach of children If swallowed, get medical help, or contact a Poison Control Center immediately.

Directions Instill

1 or 2 drops in the affected eye (s) as needed.

Inactive Ingredients Sterile

Water, Tonicity Solution Sodium Chloride. Other information Store at Room Temperature. Questions? (656) 225-2260 Indications Regener-Eyes® is formulated to provide temporary relief of burning and irritation due to dryness of the eye. Each product is preservative-free and can be used as a protectant against further irritation or to relieve dryness of the eye.

Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. when first opening the tube, peel back foil seal apply externally or in the lower portion of the anal canal only apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus thoroughly cleanse dispensing cap after each use and replace cover children under 12 years of age: ask a doctor

Directions Single D aily D osage (per 24 hours ) A dults and children 6 years and over 1 suppository or as directed by a doctor C hildren 2 to under 6 years use Fleet ® Pedia-Lax ® Liquid C hildren under 2 years consult a doctor Left-side position: Lie on left side with right knee bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably Administering the laxative: CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit with fingers. Grasp orange protective shield with other hand, pull gently to remove. With steady pressure, insert tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Do not force the applicator tip into the rectum, as this can cause injury. Insertion may be easier if person receiving suppository bears down as if having a bowel movement. This helps relax the muscles around the anus. Squeeze the bulb until nearly all liquid is expelled. While continuing to squeeze the bulb, remove tip from rectum and discard unit. It is not necessary to empty unit completely. The unit contains more than the amount of liquid needed for effective use. A small amount of liquid will remain in the unit after use. For a more detailed step-by-step instructional video on how to use Fleet ® products, visit our website www.fleetlabs.com to watch the “how to use” video.

Warnings For external use only . Do not use if solution changes color or becomes cloudy. Ask a doctor before use if you have narrow angle glaucoma. When using this product to avoid contamination, do not touch tip to any surface replace cap after using overuse may produce increased redness of the eye pupils may become temporarily enlarged Stop use and ask a doctor if you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or symptoms last for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For external use only . Do not use if solution changes color or becomes cloudy. Ask a doctor before use if you have narrow angle glaucoma. When using this product to avoid contamination, do not touch tip to any surface replace cap after using overuse may produce increased redness of the eye pupils may become temporarily enlarged Stop use & ask a doctor if you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or symptoms last for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active ingredients Purpose Glycerin 14.4%............................................................Skin protectant Phenylephrine HCl 0.25%...........................................Vasconstrictor Pramoxine HCl 1%......................................................Local anesthetic White petrolatum 15%.................................................Skin protectant

SODIUM HYALURONATE ROSA DAMASCENA FLOWER WATER ROSA DAMASCENA FLOWER OIL COFFEA ARABICA (COFFEE) SEED EXTRACT ASTROCARYUM MURUMURU SEED BUTTER DIMETHICONE BUTYLENE GLYCOL CETEARYL OLIVATE SORBITAN OLIVATE CETEARYL ALCOHOL CYCLOPENTASILOXANE ISONONYL ISONONANOATE MICA CI 77891 TIN OXIDE WATER REHMANNIA CHINENSIS ROOT EXTRACT CANOLA OIL TBHQ OLIGOPEPTIDE-1 OLIGOPEPTIDE-5 OLIGOPEPTIDE-2 TOCOPHERYL ACETATE METHYLPARABEN PENTYLENE GLYCOL AVENA SATIVA (OAT) BRAN EXTRACT ALLANTOIN EUGLENA GRACILIS POLYSACCHARIDE UBIQUINONE LACTOBACILLUS FERMENT LACTOBACILLUS FERMENT LYSATE ROSA RUGOSA FLOWER EXTRACT HYDROXYACETOPHENONE COLLAGEN HYALURONIC ACID HAEMATOCOCCUS PLUVIALIS EXTRACT CAPRYLIC/CAPRIC TRIGLYCERIDE SODIUM CHLORIDE POLYSORBATE 20 TRIPEPTIDE-1 HEXAPEPTIDE-9 PALMITOYL TRIPEPTIDE-5 PALMITOYL PENTAPEPTIDE-4 PALMITOYL TETRAPEPTIDE-7 HYDROXYPROPYL TETRAHYDROPYRANTRIOL DECAPEPTIDE-4 GLYCOPROTEINS DISODIUM PHOSPHATE DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE ACETYL HEXAPEPTIDE-8 DIMETHYL ISOSORBIDE FULLERENES PVP ISOHEXADECANE POLYSORBATE 80 SORBITAN OLEATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN MALTODEXTRIN XANTHAN GUM CYCLODEXTRIN 1,2-HEXANEDIOL