HYDRA BOND MAXIMUM SKIN THERAPY CREAM- dimethicone cream

Hydra Bond Maximum Skin Therapy Cream by

Drug Labeling and Warnings

Hydra Bond Maximum Skin Therapy Cream by is a Otc medication manufactured, distributed, or labeled by Donegal Bay Ltd, HANGZHOU KARIC COMMODITIES CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Dimethicone 2.0%

PURPOSE

Purpose:

Skin Protectant

INDICATIONS & USAGE

Uses:

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

WARNINGS

Warnings:

For external use only

When using this product, avoid contacting with eyes

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRA BOND MAXIMUM SKIN THERAPY CREAM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70990-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70990-004-01	238 mL in 1 TUBE; Type 0: Not a Combination Product	10/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/19/2016

Labeler - Donegal Bay Ltd (068443618)

Registrant - Donegal Bay Ltd (068443618)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU KARIC COMMODITIES CO., LTD		526884335	manufacture(70990-004)