ALLG ESSENTIALS WARM-UP ACCELERATOR- camphor (synthetic) cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Camphor 5%
Available from:
Global Products Group, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Counterirritant - minor arthritis pain - simple backache - muscle sprains - bruises - muscle strains - cramps
Authorization status:
OTC monograph not final
Authorization number:
72593-154-14

ALLG ESSENTIALS WARM-UP ACCELERATOR- camphor (synthetic) cream

Global Products Group, LLC

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.

----------

ALLG Essentials

Warm-up Accelerator Cream

Drug Facts

Active Ingredients

Camphor 5%

Purpos e

Counterirritant

Us es

minor arthritis pain

simple backache

muscle sprains

bruises

muscle strains

cramps

Warnings

For external use only

Do not use if

skin is irritated or damaged

excessive irritation develops

12 years of age or under

When using this product

avoid contact with the eyes and mucous membranes

do not apply to wounds, damaged, broken or irritated skin

do not bandage tightly or use a heating pad

do not swallow. If swallowed, contact a physician or contact a poison control center immediately.

Stop use and ask doctor if

condition worses

symptoms persist for more than 7 days or clear up and occur again within a few days

redness develops

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Directions

®

Directions

cleanse, rinse and dry skin prior to application

apply generously to painful muscles and joints, gently massaging until the ALLG

Warm-up

Accelerator Cream disappears.

repeat as necessary but no more than four times a day

for optimum benefit, use daily for at least two weeks.

Other

store at room temperature with the cap closed

Notice: because this product contains natural nutrients, color may vary

Inactive Ingredients

Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aescin (Horse Chestnut Extract), Aloe Vera, Arnica

Montana Extract, C12-15 Alkyl Benzoate, Calcium Fructoborate, Chondroitin Sulfate, Diazolidinyl

Urea, Dimethicone, Disodium EDTA, dl Panthenol, Glucosamine Sulfate, Glycerin, Glycerol Stearate,

Hemp Oil, Hydroxypropyl methylcellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl

Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Shea

Butter, Tocopheryl Acetate, Trolamine Salicylate

Questions or comments?

Call (877) 383-2334

PRINCIPAL DISPLAY PANEL - 114 g Jar Label

MADE WITH

HEMP

ORGANIC

ALLG

ESSENTIALS

WARM-UP

ACCELERATOR CREAM

GOOD FOR

YOGA

RUNNING

CROSS FIT

PILATIES

BOOT CAMPS

NET WT 4 OZ. (114g)

ALLG ESSENTIALS WARM-UP ACCELERATOR

camphor (synthetic) cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7259 3-154

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Ca mpho r ( Synthetic) (UNII: 5TJD8 2A1ET) (Campho r (Synthetic) - UNII:5TJD8 2A1ET)

Campho r (Synthetic)

5 mg in 10 0 g

Global Products Group, LLC

Ca mpho r ( Synthetic) (UNII: 5TJD8 2A1ET) (Campho r (Synthetic) - UNII:5TJD8 2A1ET)

Campho r (Synthetic)

5 mg in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

Methyl Gluco se Sesquistea ra te (UNII: V1YW10 H14D)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

Alkyl ( C12 -15) Benzo a te (UNII: A9 EJ3J6 1HQ)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW)

CALCITRIO L (UNII: FXC9 231JVH)

CHO NDRO ITIN SULFATE ( SHARK) (UNII: 2ZAJ1K50 XH)

Dia zo lidinyl Urea (UNII: H5RIZ3MPW4)

Io do pro pynyl Butylca rba ma te (UNII: 6 0 3P14DHEB)

Dimethico ne (UNII: 9 2RU3N3Y1O)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Escin (UNII: RUU8 G6 7GQM)

GLUCO SAMINE SULFATE PO TASSIUM CHLO RIDE (UNII: 15VQ11I6 6 N)

Glycerin (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

Methyl Gluceth-2 0 (UNII: J3QD0 LD11P)

Peppermint O il (UNII: AV0 9 2KU4JH)

Po ta ssium Hydro xide (UNII: WZH3C48 M4T)

WATER (UNII: 0 59 QF0 KO0 R)

Shea Butter (UNII: K49 155WL9 Y)

So rbita n Mo no la ura te (UNII: 6 W9 PS8 B71J)

Tro la mine Sa licyla te (UNII: H8 O40 40 BHD)

Ca nna bis Sa tiva Seed O il (UNII: 6 9 VJ1LPN1S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7259 3-154-14

114 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 3/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 3/15/20 19

Labeler -

Global Products Group, LLC (081371764)

Revised: 3/2019

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