LICE ICE- neem oil, tea tree oil gel 
NATURALRX LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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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.

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.

Lice Ice Label 4oz

LICE ICE 
neem oil, tea tree oil gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69170-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) (AZADIRACHTA INDICA SEED OIL - UNII:4DKJ9B3K2T) AZADIRACHTA INDICA SEED OIL0.937 [hp_X]  in 100 mL
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.937 [hp_X]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SULISOBENZONE (UNII: 1W6L629B4K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69170-102-14118 mL in 1 TUBE; Type 0: Not a Combination Product03/22/2020
2NDC:69170-102-18236 mL in 1 TUBE; Type 0: Not a Combination Product03/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/2014
Labeler - NATURALRX LLC (152081183)
Establishment
NameAddressID/FEIBusiness Operations
DIVERSIFIED MANUFACTURING CORP185073996manufacture(69170-102)

Revised: 3/2020
Document Id: ee88eef3-21c5-4a35-8228-12a524b44853
Set id: ac6abb20-4949-4bb1-9ffd-311dbe641548
Version: 4
Effective Time: 20200323
 
NATURALRX LLC