Hand and skin shield gel

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.

Otc - keep out of reach of children section

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.

Ingredients and appearance - Product information

Hand and skin shield gel- Dimethicone

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Dimethicone ( UNII: 92RU3N3Y1O)( Dimethicone - UNII: 92RU3N3Y1O ) 1 gin 100 mL
Mineral oil ( UNII: T5L8T28FGP)( Mineral oil - UNII: T5L8T28FGP ) 0.2 gin 100 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA 2015/04/08

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

Package label.principal display panel