NDC | 10237-742-33, 10237-742-34 |
Set ID | a7928b28-1f9b-4bcc-962a-bb01cb04d7d1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Church & Dwight Co., Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- wash hands
- cut open tip of tube on score mark
- use your fingertip or cotton applicator to apply a small, pea-size amount of Baby Orajel Naturals and spread over the gums
- apply to the affected area up to 6 times daily or as directed by a physician or healthcare provide
- for infants under 4 months of age, ask a physician or healthcare provider
Other information
Do not use if tube tip is cut prior to opening - INACTIVE INGREDIENT
-
QUESTIONS
Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm or visit our webiste at www.orajelnaturals.com
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF
calcarea phosphorica, chamomilla, coffea cruda gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-742 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X] in 1 g ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-742-33 1 in 1 CARTON 12/01/2012 1 9.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-742-34 1 in 1 CARTON 12/01/2012 2 9.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2012 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-742)