HAND AND SKIN SHIELD- dimethicone gel

HAND AND SKIN SHIELD by

Drug Labeling and Warnings

HAND AND SKIN SHIELD by is a Otc medication manufactured, distributed, or labeled by DCG Vision Marketing & Sales International Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

MINERAL OIL 50%

PURPOSE

SKIN PROTECTANT

USES

Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of chemicals, wind and cold weather.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

For external use only. If swallowed, do NOT induce vomiting. Rinse mouth with water. If symptoms develop seek medical attention. When using this product, do not get into eyes. If in contact with eyes flush with water. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

DIRECTIONS

Clean and dry hands and skin. Apply True Effects Hand & Skin Shield™ to the palm of hand and rub thoroughly into hands and skin, making sure front and back of hands including cuticles are completely covered. Allow to dry for 3-5 minutes or until completely absorbed into skin. After coming into contact with dangerous chemicals, wash hands thoroughly and reapply.

Other:

STORE IN A COOL PLACE AWAY FROM DIRECT SUNLIGHT

Inactive Ingredients:

Aqua/Water, Stearic Acid, Propylene Glycol, Glyceryl Stearate, Isopropyl Palmitate, Ricinus Communis (Castor) Seed Oil, Cyclopentasiloxane, Phenoxyethanol, Sodium Hydroxide, Dimethiconol, Ethylhexylglycerin, Xanthan Gum, Disodium EDTA, Simmondsia Chinensis (Jojoba) Seed Oil, Acrylates Copolymer, Aloe Barbadensis Leaf Extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND AND SKIN SHIELD 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69570-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CASTOR OIL (UNII: D5340Y2I9G)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
JOJOBA OIL (UNII: 724GKU717M)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69570-102-11	502 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
2	NDC: 69570-102-12	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2015
3	NDC: 69570-102-13	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/08/2015

Labeler - DCG Vision Marketing & Sales International Ltd. (252375576)