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Package Insert and Label Information: DR DEEP SKINTONER

By MineralHouse Corporation | Last revised: 1 January 2012

DR DEEP SKINTONER — glycerin and allantoin lotion
MineralHouse Corporation

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.

Active Ingredients: Glycerin 1%, Allantoin 0.1%
Purpose: Skin Protectant
Uses — Spread over the face or the body thoroughly
Warnings — For external use only
Do Not Use — On wounds or damaged skin
When using this product:
- do not use other than directed
Stop use — If allergic reaction or irritation occurs
Keep out of reach of children
Direction:
Adults and children over 3 months old
Step1: Clean and dry the face or the body
Step2: Spread a proper amount thoroughly to the face or the body
Children under 3 months old
Consult your medical professional
Storage — Keep in a dry and cool place
Inactive Ingredients:
Mineral Water, Aloe, Sodium Hyaluronate, Grapefruit Seed, Zanthoxylum Piperitum Fruit Pulp, Pulsatilla koreana Root, Usnea Barbata (Lichen) Extract
Box Label
(click image for full-size original)
DR DEEP SKINTONER glycerin allantoin lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76015-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 2 mL in 200 mL
ALLANTOIN (ALLANTOIN) ALLANTOIN 0.2 mL in 200 mL
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
ALOE
CITRUS PARADISI SEED
WATER
ZANTHOXYLUM PIPERITUM FRUIT PULP
PULSATILLA KOREANA ROOT
USNEA BARBATA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76015-300-01 200 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/01/2012
Labeler — MineralHouse Corporation (557802539)
Registrant — MineralHouse Corporation (557802539)
Establishment
Name Address ID/FEI Operations
MineralHouse Corporation 557802539 relabel, repack
Establishment
Name Address ID/FEI Operations
BoBo Cosmetics, Co 689778744 manufacture

Revised: 01/2012 MineralHouse Corporation