MOISTURIZING CREAM- dimethicone lotion 
R & R Lotion, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Moisturizing Cream™

Drug Facts

Active Ingredients

Dimethicone 4.0%

Purpose

Skin Protectant

Uses

Skin protectant, temporarily protects against harmful Pathogens & Stimuli while moisturizing dry and cracked hands.

Warnings

For external use only

  • When using this product, aviod contact with eyes
  • In case of eye contact, flush with water

  • Keep out of reach of children, except under adult supervision
  • If swallowed, get medical help

  • Discontinue use if skin irritation or redness develops.

Directions

Rub into hands and body until absorbed.

Ingredients

DI Water, Octyl Palmitate, Corn Oil, Dimethicone, Polawax, Grape Seed Oil, Sunflower Butter, Glycerin, Cetyl Alcohol, Geogard Ultra, Triethanolamine 85, Carbopol 941, Aloe Vera, Jojoba, Blue Agave, Cranberry, Strawberry, Raspberry, Pomegranate, Green Tea, Green Coffee Bean, Grape Seed, Blueberry, Acai Berry, Vitamins A, D and E

Questions or Comments?

Call (480) 443-9255 or visit RRlotion.com

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

R&R LOTION®
MOISTURIZING CREAM™

HAND CREAM

8 FL. OZ. (236ML) e

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label
MOISTURIZING CREAM 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Corn Oil (UNII: 8470G57WFM)  
Gluconolactone (UNII: WQ29KQ9POT)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Calcium Gluconate (UNII: SQE6VB453K)  
Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Grape Seed Oil (UNII: 930MLC8XGG)  
Cetyl Alcohol (UNII: 936JST6JCN)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
Trolamine (UNII: 9O3K93S3TK)  
vitamin A (UNII: 81G40H8B0T)  
cholecalciferol (UNII: 1C6V77QF41)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-801-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34712/21/2015
Labeler - R & R Lotion, Inc (062979000)

Revised: 12/2015
Document Id: 8b930340-55f7-4bbe-9577-442ba30cc1a5
Set id: 088a674e-8f24-4c0a-a302-004fa0ca168e
Version: 1
Effective Time: 20151208
 
R & R Lotion, Inc