LITTLE REMEDIES NEW BABY ESSENTIALS- acetaminophen, simethicone, zinc oxide 
Medtech Products Inc.

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.

----------

Little Remedies New Baby Essentials Kit

FOR FEVERSTM

INFANT FEVER + PAIN RELIEVER  Acetaminophen

Drug Facts                                          

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever / Fever reducer

Uses

Temporarily:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ▪ more than 5 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen.

Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other products containing acetaminophen (prescription or non-prescription).

      If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if the child has

liver disease.

Ask a doctor or pharmacist before use if the child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 5 days
  • redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

mL = milliliter

Weight (lbs)Age (yrs)Dose (mL)
Under 24under 2Ask a doctor
24-352-35 mL

Other information

Inactive ingredients

benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

FOR DIAPER RASH
BOUDREAUX’S BUTT PASTE ® Diaper Rash Ointment

Drug Facts
Active ingredient Purpose
Zinc oxide, 16%...................................................Skin protectant
Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
When using this product avoid contact with the eyes
Stop use and ask a doctor if condition worsens or does not improve after 7 days
Keep out of the reach of children to prevent accidental ingestion
If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately
Directions
  • Change wet and soiled diaper immediately
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
Other information
  • Store at room temperature 20°- 27°C (68°- 80°F)
  • Remove seal from jar before use
  • Use with infants, children and adults
  • Will stain clothing and fabric
Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum
Questions?
1-855-785-2888 www.buttpaste.com

FOR TUMMYSTM

GAS RELIEF DROPS Simethicone / Antigas

Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg

Purpose

Antigas

Uses

Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food

Warnings

Keep out of reach of children.

Directions

■ shake well before using

■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek

■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.

■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids

■ for best results, clean syringe after each use and replace original cap

If possible, use weight to determine dose; otherwise use age.

mL = milliliters

Age (yrs)Weight (lbs)Dose
Newborns &
Infants under 2 years
under 240.3 mL
Children 2 years and over24 and over0.6 mL

Other information

■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)

■ See bottle or box for lot number and expiration date

Inactive ingredients

carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

FOR TUMMYSTM

GRIPE WATER

Supplement Facts
Serving Size: 5 mL
Servings per Container: about 12
Amount per Serving% Daily Value
Zingiber officinale (Ginger) Root Extract       5 mg      
Foeniculum vulgare (Fennel) Seed Extract       4mg
†Daily Value not established

Other ingredients

purified water, agave, glycerin, natural ginger flavor, potassium sorbate, citric acid, xanthan gum

Suggested Use
AgeDose
2 to 4 weeks2.5 mL
1 to 6 months5 mL
6 months and older10 mL
Adults30 mL

SHAKE WELL. May be taken directly using the dispenser included. May be given up to six times in a 24 hour period. If necessary to repeat dosage, wait a minimum of 30 minutes. Do not use if safety seal is broken or missing.

Keep out of reach of children.

In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.

Do not use if

▪ child has a history of kidney failure or renal problems ▪ child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant. ▪ Store at room temperature.

FOR NOSESTM

SALINE SPRAY + DROPS 

Uses

–Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator.

Warnings

Keep out of reach of children.

▪ The use of this dispenser by more than one person may spread infection.

▪ Wipe nozzle clean after each use.

Directions

(For nasal use only)

▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. 

▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor.

Store at 20°-25°C (68°-77°F).

See bottle for lot and expiration date.

Ingredients:

water, sodium chloride, glycerin, sodium benzoate, benzoic acid

PRINCIPAL DISPLAY PANEL

Little Remedies®

New Baby Essentials Kit

INFANT FEVER/PAIN RELIEVER

ACETAMINOPHEN / FEVER/PAIN RELIEVER

2 FL OZ (59 mL)

Syringe Included

GAS DROPS

SIMETHICONE /ANTIGAS

1 FL OZ (30 mL)

Syringe Included

DIAPER RASH OINTMENT

ZINC OXIDE / SKIN PROTECTANT

2 OZ (57 g)

SALINE SPRAY + DROPS

0.5 FL OZ (15 mL)

GRIPE WATER

GINGER / FENNEL SUPPLEMENT

2 FL OZ (59 mL)

Syringe Included

Nasal Aspirator

PRINCIPAL DISPLAY PANEL

Little Remedies®
New Baby Essentials Kit

INFANT FEVER/PAIN RELIEVER 
ACETAMINOPHEN / FEVER/PAIN RELIEVER 
2 FL OZ (59 mL)
Syringe Included

GAS DROPS
SIMETHICONE /ANTIGAS
1 FL OZ (30 mL)
Syringe Included

DIAPER RASH OINTMENT 
ZINC OXIDE / SKIN PROTECTANT  
2 OZ (57 g) 

SALINE SPRAY + DROPS 
0.5 FL OZ (15 mL)

GRIPE WATER 
GINGER / FENNEL SUPPLEMENT
2 FL OZ (59 mL)
Syringe Included

Nasal Aspirator

LITTLE REMEDIES NEW BABY ESSENTIALS 
acetaminophen, simethicone, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-615
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-615-011 in 1 CARTON; Type 0: Not a Combination Product02/15/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 59 mL
Part 21 BOTTLE 30 mL
Part 31 TUBE 57 g
Part 41 BOTTLE 59 mL
Part 51 BOTTLE 15 mL
Part 1 of 5
LITTLE REMEDIES INFANT FEVER AND PAIN RELIEVER 
acetaminophen liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/15/2017
Part 2 of 5
LITTLE REMEDIES RELIEF 
simethicone liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33202/15/2017
Part 3 of 5
BOUDREAUXS 
zinc oxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
BALSAM PERU (UNII: 8P5F881OCY)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorWHITE (Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/15/2017
Part 4 of 5
GRIPE WATER 
ginger and fennel liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER5 mg  in 5 mL
FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL4 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT02/15/2017
Part 5 of 5
SALINE 
other baby products spray
Product Information
Route of AdministrationNASAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRPOTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
INGRBENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC02/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/15/2017
Labeler - Medtech Products Inc. (122715688)

Revised: 3/2019
Document Id: 0a57e76e-63e0-4cae-98b2-3b36622c51d0
Set id: 4b1b7294-aca6-45fa-a008-c1869131b2a3
Version: 1
Effective Time: 20190311
 
Medtech Products Inc.