HYDRA BOND MAXIMUM SKIN THERAPY CREAM- dimethicone cream 
Donegal Bay Ltd

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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Daily Moisturizing Lotion

Active Ingredient:

Dimethicone 2.0%

Purpose:

Skin Protectant

Uses:

Helps protect, prevent, and relieve dry, itchy, chaffed or chapped skin from the drying effects of the elements.

Warnings:

For external use only

When using this product, avoid contacting with eyes

In case of accidental ingestion get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions:

Apply frequently and generously to skin as needed. Reapply to specific. extremely rough, dry, problem area to promote healing.

Inactive Ingredients:

Water, Glycerin, Petrolatum, Jojoba Ester, Cetyl Alcohol, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Distearyldimonium Chloride, Cetearyl Alcohol, Steareth-21, Steareth-2, Propylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Methyl Glueth-20, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Panthenol (Vitamin B5), Retinol (Vitamin A), Hydrolyzed Collagen, Disodium EDTA, Fragrance, triethanolamine, Methylparaben, Propylparaben

image description

HYDRA BOND MAXIMUM SKIN THERAPY CREAM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70990-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARETH-2 (UNII: V56DFE46J5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PANTHENOL (UNII: WV9CM0O67Z)  
RETINOL (UNII: G2SH0XKK91)  
DISODIUM HEDTA (UNII: KME849MC7A)  
TRIETHANOLAMINE LAURATE (UNII: 9403LC9W1J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70990-004-01238 mL in 1 TUBE; Type 0: Not a Combination Product10/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/19/2016
Labeler - Donegal Bay Ltd (068443618)
Registrant - Donegal Bay Ltd (068443618)
Establishment
NameAddressID/FEIBusiness Operations
HANGZHOU KARIC COMMODITIES CO., LTD526884335manufacture(70990-004)

Revised: 10/2016
Document Id: 2e9e8f7a-c70b-433f-b958-37ea2c2ec374
Set id: 6e201ef5-094e-4dc7-b5fd-610d7f7ff70b
Version: 1
Effective Time: 20161012
 
Donegal Bay Ltd