NATUREPLEX HEMORRHOIDAL- witch hazel and phenylephrine hydrochloride gel

Natureplex by

Drug Labeling and Warnings

Natureplex by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Phenylephrine HCl 0.25%	Hemorrhoidal (anorectal) Gel
Hamamelis Virginiana (witch hazel) 50%	Hemorrhoidal (anorectal) Gel

Uses

• temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
• temporarily reduces the swelling associated with irriation in hemorrhoids and other anorectal disorders
• temporarily shrinks hemorrhoidal tissue
• aids in protecting irritated anorectal areas
• temporary relief of burning

Warnings

For external use only.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor
• do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• bleeding occurs
• the condition worsens or does not improve within 7 days. These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults:

• when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel.
• apply externally to affected area up to 4 times daily or after each bowel movement
• Children under 12 years: ask a doctor

Other information

• store at 15 to 30°C (59 to 86°F)
• close cap tightly after use
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 25.5 g Tube Box

NDC: 67234-024-01

Natureplex™

Anesthetic
HEMORRHOIDAL
Cooling Gel With Soothing Aloe

NET WT. 0.9 Oz.(25.5g)

Fast Cooling Relief

INGREDIENTS AND APPEARANCE

NATUREPLEX   HEMORRHOIDAL
witch hazel and phenylephrine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.5 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.0025 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOPHENONE (UNII: 701M4TTV9O)
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-024-01	1 in 1 BOX	03/18/2014
1		25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	03/18/2014

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-024)