Label: FROSTED BERRIES AND CREAM SANITIZER PEN- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 34460-6005-1, 34460-6005-2 - Packager: Zhejiang Blue Dream Cosmetics Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 22, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DESCRIPTION
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WARNINGS
Warnings:
For external use only
Flammable. Keep away from heat and flame.
When using this product
- Keep out of eyes. In case of contact with eyes, flush thoroughly with water
- Avoid contact with broken skin
- Do not inhale or ingest
Stop use and ask a doctor if skin irritation develops
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FROSTED BERRIES AND CREAM SANITIZER PEN
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34460-6005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 35.16 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 2.0 g in 100 g TROLAMINE (UNII: 9O3K93S3TK) 0.2 g in 100 g CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.2 g in 100 g POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.1 g in 100 g DMDM HYDANTOIN (UNII: BYR0546TOW) 0.2 g in 100 g FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.003 g in 100 g FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.002 g in 100 g FD&C RED NO. 40 (UNII: WZB9127XOA) 0.005 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:34460-6005-1 10 g in 1 BOTTLE 2 NDC:34460-6005-2 90 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 08/07/2010 Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234) Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234) Establishment Name Address ID/FEI Business Operations Zhejiang Blue Dream Cosmetics Co., Ltd. 529047234 manufacture