X-PEL ANTI-LICE- apis mellifica, carbolicum acidum, ledum palustre shampoo

X-PEL Anti-Lice by

Drug Labeling and Warnings

X-PEL Anti-Lice by is a Homeopathic medication manufactured, distributed, or labeled by Briangeli Beauty Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Apis Mellifica 15x

Carbolicum Acidum 15x

Ledum Palustre 15x

PURPOSE

NON-TOXIC

Professional Formula

X-PEL™

Anti-Lice Shampoo & Conditioner

• Eliminates Lice
• Works in Just 10 Minutes
• Stops Itching
• Eases Egg Removal
• Leaves Hair Soft, Shiny & Tangle-Free
• Repels Lice
• Pediatrician and Dermatologist Approved

6 fl. oz. (177 mL)

NDC: 11727-6-06

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Indications

For treatment of pediculosis.

• Eliminates Lice
• Makes eggs easy to remove
• Stops itching caused by lice bites

WARNINGS

Warnings

For external use only. Avoid contact with eyes.

If eye contact occurs, rinse with clear water.

Keep out of reach of children.

Safe for ragweed sufferers.

DOSAGE & ADMINISTRATION

Directions

SHAKE WELL BEFORE USE

1. Wet hair with warm water.

2. Apply X-PEL™ liberally and massage into wet hair until a thick lather forms.

3. Leave lather on hair for 10 minutes. Do not rinse.

4. Divide hair into sections and comb with the NitPro-II™ comb to remove lice and eggs. Rinse comb after each stroke. For instructions on how to use the comb read the insert inside the box.

5. Rinse hair with warm water. Repeat steps 2-4.

6. Finally, rinse the hair with warm water, towel dry and inspect for and comb out any remaining eggs. Clean comb with hot water and store for future use.

INACTIVE INGREDIENT

Other ingredients

water, cocamidopropyl betaine, pyroligeneous acid purified (USP), amodiemethicone & tallowtrinionium chloride & nonoxynol-10, glycerin (USP), ethylene glycol distearate, polyquaternium-10, fragrance, diazolidinyl urea, methylparaben, proplyparaben, tetrasodium EDTA, FD&C blue no.1, FD&C yellow no.5

OTHER SAFETY INFORMATION

Cruelty Free Testing

Environmentally Safe

Homeopathic Formula

Distributed By: Dermedics Laboratories

335 Sniffen Lane, Stratford, CT 06615

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

X-PEL ANTI-LICE 
apis mellifica, carbolicum acidum, ledum palustre shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68971-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	15 [hp_X]  in 170 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	15 [hp_X]  in 170 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	15 [hp_X]  in 170 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PYROLIGNEOUS ACID (UNII: N4G9GAT76C)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68971-001-06	170 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/15/2014

Labeler - Briangeli Beauty Enterprises (010656161)

Establishment
Name	Address	ID/FEI	Business Operations
Briangeli Beauty Enterprises		010656161	manufacture(68971-001)