LICE ICE COLOR-FREE- neem, tea tree gel

LICE ICE by

Drug Labeling and Warnings

LICE ICE by is a Homeopathic medication manufactured, distributed, or labeled by NATURALRX LLC, DIVERSIFIED MANUFACTURING CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

NEEM OIL.....0.937 X

TEA TREE OIL.....0.937 X

PURPOSE

LICE TREATMENT

WARNINGS

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

USES

TREATS HEAD LICE

DIRECTIONS

TREATMENT: APPLY LICE ICE GEL GENEROUSLY TO DRY HAIR. MASSAGE WELL DOWN INTO SCALP AND ROOTS, MAKING SURE TO GET ALL THE HAIR ENCASSED IN THE GEL. ALLOW LICE ICE TO AIR DRY COMPLETELY. LEAVE ON 12 TO 15 HOURS. DO NOT COVER THE HAIR. IF PROPERLY APPLIED, ALL LICE AND EGGS WILL BE ENTIRELY ENCASED IN A HARDENED GEL, MAKING IT IMPOSSIBLE FOR LICE TO FEED, LAY EGGS, OR FOR EGGS TO HATCH. VIGOROUSLY SHAMPOO WITH REGULAR SHAMPOO, RINSE WELL. DRY HAIR. THOROUGHLY INSPECT HAIR AND SCALP, REAPPLY IF NECESSARY.

PREVENTATIVE:

USE LICE INE IN PLACE OF DAILY STYLING GEL ON WET OR DRY HAR OR DILUTE LICE ICE GEL 1:4 IN WATER AND APPLY TO WET OR DRY HAIR AND SCALP AS A SPRAY. REINFESTATION IS LIKELY IF THE LIVING ENVIRONMENT HAS NOT BEEN CLEANED. PLEASE VISIT WWW.LICEICE.COM FOR MORE INFO.

INGREDIENTS:

PURIFIED WATER, SD ALCOHOL, PVP/VA COPOLYMER, POLYQUATERNIUM 11, TRAGACANTH GUM, DIMETHICONE COPOLYOL, CARBOMER 940, TRIETHANOLAMINE, EMPIRE ORGANICS SPECIAL BLEND OF NEEM, TEA TREE, LEMON, LAVENDER, THYME AND ROSEMARY ESSENTIAL OILS, FD&C BLUE NO. 1, FRAGRANCE, BENZOPHENONE 4.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LICE ICE  COLOR-FREE
neem, tea tree gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69170-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) (AZADIRACHTA INDICA SEED OIL - UNII:4DKJ9B3K2T)	AZADIRACHTA INDICA SEED OIL	0.937 [hp_X]  in 100 mL
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	0.937 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
LAVENDER OIL (UNII: ZBP1YXW0H8)
THYME OIL (UNII: 2UK410MY6B)
ROSEMARY OIL (UNII: 8LGU7VM393)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
TRAGACANTH (UNII: 2944357O2O)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
SULISOBENZONE (UNII: 1W6L629B4K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69170-103-14	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/15/2014
2	NDC: 69170-103-18	236 mL in 1 TUBE; Type 0: Not a Combination Product	08/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/2014

Labeler - NATURALRX LLC (152081183)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(69170-103)