Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) (CAMELLIA JAPONICA SEED OIL - UNII:U37N0S910T)
MIGUHARA
TOPICAL
OTC DRUG
Purpose: Skin Protectant
unapproved drug other
CAMELIA FACIAL- CAMELLIA JAPONICA SEED OIL MIGUHARA _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- ACTIVE INGREDIENT Active Ingredient: Bacillus/Camellia Japonica Seed Oil 99.5% INACTIVE INGREDIENT Inactive Ingredients: Tocopherol PURPOSE Purpose: Skin Protectant WARNINGS Warnings: 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN US AGE Usage: Take an appropriate amount and gently apply it on the face. US AGE Usage: Take an appropriate amount and gently apply it on the face. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL CAMELIA FACIAL camellia japonica seed oil PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:70 38 0 -150 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY MIGUHARA INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CAMELLIA JAPO NICA SEED O IL (UNII: U37N0 S9 10 T) (CAMELLIA JAPONICA SEED OIL - UNII:U37N0 S9 10 T) CAMELLIA JAPONICA SEED OIL 34.8 g in 35 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH TO CO PHERO L (UNII: R0 ZB2556 P8 ) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70 38 0 -150 -0 1 35 mL in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappro ved drug o ther 0 1/0 2/20 16 LABELER - MIGUHARA (689204213) REGISTRANT - MIGUHARA (689204213) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS MIGUHARA 6 8 9 20 4213 ma nufa c ture (70 38 0 -150 ) Revised: 2/2016 Read the complete document